I ..

SUPPLEMENT 1-3 I!

WITH CUMULA. TIVE INDEX ~ 980 EDITION

APPROVED PRESCRIPTION DRUG PRODUCTS

WITH THERAPEUTIC EQUIVALENCE

EV ALUA nONS

u.s. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUOLIC HEALTH SErWICE

FOOD AND Dfl,UG ADMINISTMTION OUfl,EAU OF Dfl,UGS

--- - ---------------

F'CDD AND DRU:; ADMINISTRATION APPROVED PREOCRIPTION DRU:; PRODOCTS

WITH 'IHERAPEUTIC EQUIVAI.EN:E EVALUATIONS

SUPPLEMENT

I. PRE:rnCE

This suwlement is one of a series of periodic up:3ates to the list of Approved Prescription Drug Products with Therapeutic Equivalence Evaluations (the List) to cover revisions interim to the annual publication of the List in its entirety. This suwlement contains updates to the Drug Product List and Appendix portions of the List, as VJell as cumulative indices for both.

1. Drug Product List

The Drug Product List reV1Slons are intended to be pen and ink changes to the annual publication of the List rather than page replacements or cut-and-paste changes. The changes in this supplement contain revisions made since the last publication or previous supplement.

In general, information in this listing follows the format of the Drug Product List. Information to be deleted from the Drug Product List is indicated by an overstruck print. Information to be added to the Drug Product List is indicated by the symbol>~> to the left of the line on which new information exists. Any line containing neither the overstruck print nor>~> is necessary to provide the context information needed to assist in locating the proper place in the Drug Product List for the revision.

A change of information concerning a given drug product covers only enough context information to facilitate making the change. The change itself is indicated by deleting the old information, directly followed by adding the nEW information.

The addition of a therapeutic equivalence code indicates that the drug product has beccme multisource~ the deletion of a therapeutic equivalence code indicates that the drug product has become single source. A change in the therapeutic equivalence code is indicated by a delete, immediately followed by an add on the line below indicated by an > _{\DD >

-2-

2. Appendix--Prescription Drug Products Deemed Approved Pendjng Resolution of Safety or Effectiveness Issues

The listing for the Appendix contains only drug products which are the subject of additions, removals, or classification changes within the Appendix. These revisions are indicated in the same manner as addition and removal of drug products for the Drug Product List.

3. Cumulative Indices

Each supplement is accompanied by a cumulative index. These are intended to provide a ready record of all revisions occurring from one annual List publication to the next. Each index will be alphabetical, the Drug Product List by ingredient and the Appendix by trade name.

II. SPECIAL NOTES

1. The 2nd Edition of this publication is scheduled to be available as a new subscription from the Government Printing Office (GPO) in October, 1981. It will contain data current through July, 1981. The first supplement to that edition will contain updates covering both August and September, 1981, and is intended to be distributed by GPO with the publication. All supplements to the 2nd Edition will be provided as part of the base subscription price.

2. A subscription form has been provided at the end of this supplement to assist in extending the subscription to this publication through the 2nd Edition (1981 publication).

II

a..:" Wi

• ACETAMINOPHEN; CODEINE PHOSPHATE

ELIXIR; ORA L ACETAM!HOrHEH WI CODE!NE

• APPROVEO PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST SUPPLEMENT NUMBER 13

>~> ATENOLOL

TABLET; ORAL THIORMIN I

,·-_"""?",~,,q;B:~

1

>~> AA PHARM ASSOCIATES lZOMG/SHL;12HG/SHL

>~>

>i!2!L>

>~> STUART PHAR~S/ICI I

SOMG * IOOMG

>~>

ACETIC ACID, GLACIAL

SOLUTION; OTIC ACETASOL

>-AillL> AT NATL PHARM MFG/BARRE 27.

> -AillL>

> ADQ....>

AMINO ACIDS

INJECTABLE; INJECTION

! /#r!#.Yrl/li / AMH~OSYN-RF 5.2%

ABBOTT LABS ! #/ 5.2%

AMINOPHYLLINE

INJECTABLE; INJECTION AHltmrIlYlL!NE

> .-M1!L > AI' L YPHO-tIED 25MG/HL

ASPIRIN; BUTALBITAL; CAFFEINE; PHENACETIN

TABLET; ORAL BUTAL~!TAl WI APC

>~> AS LEDERLE LABS/AM CYAN ZOOMG;SOMG;40MG;130MG

ATROPINE SULFATE; IOIPHENOXYLATE HYOROCHLORIDE

TABLET; ORAL DIFHEliO)(YLATEIHCL WI ATROl'!"'E SULFATE

>~> AA PREMO PHARM I LABS 25 U~H;2.5MG

CALCIUM CHLORIDE; I DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUMILACTATE

INJECTABLE; INJECTION DEXTROSE 5Y. !~ LACTATED RINGER'S IH PLASTIC COHTA!NER

>-AillL> AI' CUTTER LABSI 2nHG/IOOHL;59~~/10Ct!L;!CHG/IOOHL; > -ARJL> AI'

CH LORTHA LIDONE i

>~> AS >-AillL> AS

I

TABLET; ORAL I CHUlRTHAL!DOHE

I

CHElSEA LABS !

DAHBURYPHAr'ACAL

CORTISONE ACETATEI

> -AillL>

i INJECTABLE; INJECTION

I CORTISONE ACE~ATE

!p,!)'( '##rl#¥,J,fNlt:f,/ LE~'t'ON I

6 COHGn0011L; 31 O:'I~/I0I)ML

25MG t! SaM~ ?.-?HG t! 50.H~

APPROVED PRESCRIPTION DRUG PRODUCTS DRUG PRODUCT LIST

SUPPLEMENT NUMBER 13

!;"YP'30HEPTADINE HYDROCHLQRIDE FUROSEMIDE

>2Q!L> AA

TABLET; ORAL CYr-~OHEPTAOrHF. Hel

PREtlO F'HARM LABS 4MGI

I

DIHYDROERGOCORNINE MESYLATE; DJHYDROERGOCRISTINE MESYLATE;

AA

I

DIHYDROEPGOCRYPTINE MESYLATE

TABLET; SUBLINGUAL DI!iYN~OET!50T"XINE METtI.'~NES~~lFOt{'!lTE

-_. !U-/w;t,Tm 'MrUU.J'udH 'f! KV PHAPMCEUTICAL ERGO Lorn HESYLATES

BARR LABS 167 lSH;167 USH;167 UGH * 333 UGH; 333 1l'!:;H;;~

TABLET; ORAL lAsrx

> ADD > AS HOECHST-ROUSSEL >-ARJL> FURO!iEH!OE

>~> AS MYLAN PH ARMS

GLYCOPYRROlATE

TABLET; ORAL GLYCOPYRROlATE

>~> AA DANBURY PHARNACAL

2

20MG * 40MG

20HG * 40NG

1HG * 2MG >2Q!L> AA >2Q!L> At!.

>~..P_> AA KV PHARMACEUTICAL 167 iUG'!; 167 UGH;16 7 UGN HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

ERYTHROMYCIN ETHYLSUCCINATE I

SUSPENSION; OR;\L

AS

>2Q!L> AS

E~YTli~t'HYCIN ETHYlSl'CCIHATE

NATL PHARM MFG/BARRE Eg ZOO!"lG BASE/SNL * Eg ~OOHG BASE/SML

ESTROGENS, CONJUGATED

>2Q!L> BS

--

TABLET; ORAL CONJUGATED ESTROGENS

CHELSEA LABS 6251UGN * 1.25NG * 2.5NG

e

TABLET; ORAL >~> HYDROCHLOROTHIAZIDE/HYDRALAZINE HCL/RESERPINE >~> BP DANBURY PHARMACAL

HYDROCHLOROTHIAZIDE

>~> AS AS

>~>

>~> AS

TABLET; ORAL HYDROCHlOROTHIAZrDE

PUREPAC PHARM REID-PROVIDENT LABS

ZInE

REID-PROVIDENT LABS

HYDROCORTISONE

OINTMENT; TOPICAL HY!lROCORT:!SOHE

25MG;15MGilOO UGN

2!'~IG * SONG 2!'HG '!,'id~,j/

SOMG

AT SHAFFER-DAVIS LABS o.S7.',J,'jjj, >~> AT THAMES PHARMACAL 17.

fit

• HYDROCORTISONE ACETATE

INJECTABLE; INJECTION HYDROCORTISONE ACETATE

!P'!~, '?#f#,r!,E~jj#t:j,/ >~> LEMMON

HYDROXYZINE HYDROCHLORIDE

INJECTABLE; INJECTION HYOP-OXYZINE HCL

> ...AQJL> AP L YPHO-tlED >-AQ~> AP NATCON CHEMICAL

HYDROXYZINE PAMOATE

CAPSULE; ORAL >~> HYDROXYZINE PAMOATE

> _ADD > AB BOLAR PHAR~l

>...AQ~> AS

>~> Al3

>~> AS

V:r-,"TA~!L

PFIZER LABS

>~~> IODOXAM~TE MEGLUMINE

> ~> INJECTABLE; II'-IJECTION >~> CHOLOVUE

• APPROVED PRESCRIPTION DRUG PRODUCTS

DRUG PRODUCT LIST SUPPLEMEtH NUMBER 13

2SMG/HL 'IE S()HGlML 2SHG/HL 'IE SOMG/HL

Eq 25HG HCL 'IE Eg SONG HCL 'IE Eq IOOHG HCL

Eq 2SMG HCL 'IE Eg SOMG HCL 'IE Eg lO0!1G HCL

I LEVOPROPOXYPHENE NAPSYLATE

. I

SUSPENSION; ORAL

NOVRAD I

/ '.1 '.I ".I "PI F,Lf, )'f,Lj-, I. >...AQ~> ELI LILLY I, INDSTRS/PR

LIDOCAINE

OINTMENT; TOPICAL

LIDOCAINE I >~> AT THAMES PH~RMACAL

METHOXSALEN

>...MUL> CAPSULE; ORAL >~> OXSORALEN

I >...MUL> ELDER PHArS

I LOTION; TOPICAL

°/;J~t,~~:it##/ >~> ELDER PHARMS

METHYLDOPA

I

> ADD> SUSPENSION; ORAL >~> ALDCMET I

> ....A.QIL> ER SQUIBB AND SONS 9.9% * 40.3% >~> MERCK SH/'r & DOHME

>~>

LEVOPROPOXYPHENE NAPSYLATE

CAPSULE; ORAL NOvrlAD

1.1(1I1J'U/ I F, f, j-fj-, , ELI LILLY INDSTRS/PR > ADD >

PHENDIMETRAZINEITARTRATE

TABLET; ""AL l METRA

/p)/, '#HJ(' p!Vl-/-p/! ONEAL JONES&FELDMAN

I

3

S~

10MG

250MG/5ML

POTASSIUM CHLOPIDE

ItlJECTABLE; ItlJECTIOH F'OTAS~IUM Cl"L()~!DE

I

I

I >...AQJL> AP LEM~10N 211EQ/ML

PREDNJSOLONE ACETATE

INJECTABLE; INJECTION PREONISOLONE ACETATE

/p'!r~, '/~!Pl~lct.JHl/#1 > -A.!llL > LEtl~10N

PROCAINAHIDE HYDROCHLORIDE

>..AQJL> BC >~>

>...AQJL> Be

TABLET, CONTROLLED RELEASE; ORAL

PROCAt~ I PARKE-DAVIS/W-L SOOt1G

PROI~ESTn-SR I ER SQUIBB AND SONS SOONG

PROCAINE HYDROCHLORIDE

>...AQJL>

> ADD>

-

INJECTABLE; INJECTION PRO'CA!HF. HCL

/ p,!~, 'N#iV#,Jf;f.#//,J LEHMON

QUINIDINE SULFATE

TABLET; ORAL QUIH![INE SULrATE

/##/-/-,'pp,JN REXALL

APPROVED PRESCRIPTION DRUG PRODUCTS DRUG PRODUCT LIST

SUPPLEMENT NUMBER 13

>..AQJL>

>..AQJL>

>..AQJL>

SULF .

•

TRIA~ICINOLONE ACETONIOE

CREAM; TOPICAL TR:tAMCIHr.lLOHE AI'~IHOHID E

/'~#fI#,!~,i.;J#,'/-/#/ > ADO> THAtIES PHARMACAL

TRIAMCINOLONE OIACETATE

INJECTABLE; INJECTION TRIAMcnmLONE OIACETATE

/~A{ 'f~i#J#pfj#/-,S/ > -A!2!L> LEtIMON

TRISULFAPYRIMIDINES

SUSPENSION; ORAL SUL~ALO:tO

/ p,J/, ',#N#pJV../-/-p// >-A!2!L> ONEAL JONES&FELOMAN

> .-.AmL> VERAPAMIL HYDROCHLORIDE

>-A!2!L> INJECTABLE; INJECTION >-A!2!L> ISOPTIN >-A!2!L> KNOll PHARM 2.5MG/HL

.... -~'''.,

• APPROVED PRESCRIPTION DRUG PRODUCTS DRUG PRODUCT LIST

SUPPLEMENT NUMBER 13

ry,"\I1::';f,?;f\~~~~$l~~~!~~~1'F e" ,""',',,' 5

e

APPROVED PRESCRIPTION DRUG PRODUCTS DRUG PRODUCT LIST

CUMULATIVE INDEX

INGREDIENT( S) I

SUPPLEMENT: 1 2

ACETAMINOPHEN; CODEINE PHOSPHATE X X ACETIC ACID, GLACIAL

I

X ACETYLCHOLINE CHLORIDE ALBUTEROL

I AMANTADINE HYDROCHLORIDE

AMINO ACIDS AMINOGLUTETHIMIDE AMINOPHYLLINE X AMITRIPTYLINE HYDROCHLORIDE X AtfOXAPINE X

AMOXICILLIN TRIHYDRATE I X AMPICILLIN/AMPICILLIN TRIHYDRATE ASPIRIN; BUTALBITAL; CAFFEINE; PHENACETIN ASPIRIN; CAFFEINE; PHENACETIN; PROPOXYPHENE HYDROCHLORIDE ATENOLOL

I ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE X BACAMPICILLIN HYDROCHLORIDE BACI1?d.CIN BETHANECHOL CHLORIDE BETHANIDINE SULFATE

BISHYDROXYCOUMARIN BROMPHENIRAMINE MALEATE BUTABARBITAL SODIUr1 CAFFEINE; ERGOTAMINE TARTRATE CALCIFEDIOL X

I CALCIUM CHLORIDE; DEXTROSE; HA~NESIUH CHLORIDE; POTASSIUM

CHLORIDE; SODIUM ACETATE; SOO]Utl CHLORIDE CALCIUM CHLORIDE; DEXTROSE; MA~NESIUtl CHLORIDE; POTASSIUM

CHLORIDE; SODIUM ACETATE; SOD]Utf CHLORIDE; SODIUM CITRATE CALCIUM CHLORIDE; DEXTROSE; MA9NESIUI1 CHLORIDE HEXAHYDRATE;

SODIUM ACETATE; SODIUr1 CHLORI~E X CA LC IUM CH LOR ID E; 0 E XTR 0 5 E; POliASS IUM CH LOR ID E; SOD IUM

CHLORIDE; SODIUM LACTATE

I CAPTOPRIL

CARBINOXAtlINE MALEATE CEFADROXI L tlOt-1OHYDRATE CEPHALORIDINE CHLORAtIPHENICOL; DESOXYRIBONUCL EASE; FIBRINOLYSIN CHLORAMPHENICOL; HYDROCORTISONE ACETATE X

CHLORDIAZEPOXIDE HYDROCHLORIDE I CHLOROQUINE PHOSPHATE X CHLOROTHIAZIDE CHLORPHENIRAMINE MALEATE CH LORPRDt1AZINE HYDROCH LORIDE X

e

6

3 4 5 6 7 B 9 10 11 12 13

X X X X

X X

X -

X X X X

X X X X

X X X

X X

X X X X X

X X

X

X X X X

X X X

t-- --- -".-

X

X

X X

f--- - --X

X X X

X

f-- -X

X X X X X X X X X X

fa

• INGREDIE

CHLORPRO CHLORTHA CHnlOTRY CLORAZEP CLORAlEP

CORTI SON CORTISOlI CROTAtHT CYCLACIL CYCLOTHI

CYPROHEP DACARBAZ DANAlOL DEXAMETH DEXAI1ETH

DEXAtIETH DEXCHLOR DEXTROAtl DEXTROSE DEXTROSE

DEXTROSE ACETATE

DEXTROSE ACETATE

DEXTROSE SODIUM

DEXTROSE DEXTROSE

DIATRIlO DIATRIlO DIAZEPAM DICU~14RO

DIETHYLS

DIHYDROE DIHYDRO

DUIENHYD DINOPROS DINOPROS DIPHEtJAD

• APPROVED PRESCRIPTION DRUG PRODUCTS DRUG PRODUCT LIST

CUMULATIVE INDEX

NTCS) SUPPLEMENT: 1 2

PMlIDE LIDONE PSW ATE DIPOTASSIUM X ATE tlONOPOTASSIUM

E ACETATE E ACETATE; NEOMYCIN SULFATE X ON LIN AZIDE

TADINE HYDROCHLORIDE INE

X ASONE ASONE SODIUM PHOSPHATE X

ASmlE SOD IUM PHOSPHATE; NEmlYCIN SULFATE X PHENIRAMINE MALEATE PHETAMINE SULFATE X

X ; LIDOCAINE HYDROCHLORIDE

; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ; SODIUM CHLORIDE ; tIAGt'ESIU~l CHLORIDE; POTASSIUM CHLORIDE; SODIUM ; S09IUM CHLORIDE; SODIUM GLUCONATE X ; POTASSIUtl CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; ACETATE; SODIUM CHLORIDE ; POTASSIUM CHLORIDE i SODIUM CHLORIDE - IN PLASTIC X i SODIUM CHLORIDE

-- -ATE MEGLUtlINEi DIATRIlOATE SODIUM "TE SODIUtl

L TILBESTROL

RGOCORNINE MESYLATE; DIHYDROERGOCRISTINE MESYLATE; ERGOCRYPTINE MESYLATE RINATE TONE TONE(PROSTAGLANDIN E-2) IOtJE X ------

DIPHENHY DrSULFIR DOPAtHNE DOXEPIN DOXYCYCL

DRAMINE HYDROCHLORIDE t.M

HYDROCHLORIDE HYDROCHLORIDE INE HYCLATE

• 7 3 4 5 6 7 8 9 10 11 12 13

X X X X X X X X X

X

X

X

X X

X

X X X X X '. X

X

I

X X X

X X

X X X

X

X

X

X

X X

X X

X

X X X X X X

X X

X X X

X X X

X

APPROVED PRESCRIPTION DRUG PRODUCTS DRUG PRODUCT LIST

CUMULATIVE INDEX

INGREDIENT( S) I

SUPPLEMENT: 1 I 2 I 3 I 4 I 5 I 6 I 7 I 8 I 9 110 III 112 1 13

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE ERYTHRmlYCIN i ERYTHROMYCIN ETHYLSUCCINATE I ESTRADIOL VALERATE I ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE

ESTROGENS, CONJUGATED ESTROGENS, ESTERIFIED FENOPROFEN CALCIUM FENOPROFEN CALCIUM DIHYDRATE FLUORESCEIN SODIUM

X I I X X I I X

X I ) X I X X

X

X I I X I X X

X X I X

X

I

'I

------- ' f--F LUOXnlESTERONE I FOLIC ACID I

X I X

FOLLICLE-STIMULATING HORMONE; LUJENIZING HORMONE FUROSEMIDE I GENTAMICIN SULFATE

GLUTETHIMIDE I GLYCOPYRROLATE I GRISEOFULVIN, ULTRAMICROCRYSTALLINE X

X

X X

X I X

X

X X

X

X

HEPARIN SODIUM HEXACHLOROPHENE HEXOCYCLIUM METHYLSULFATE HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

X

X I I X I ~ I X I I ~ I I X

HALOTHAtlE 1 HEPARIN CALCIU~1--------------T-I--------------+--t---+--+---t--+--+---+-+---'-II---+--+

I HYDROCHLOROTHIAZIDE; RESERPINE

I

RESERPINE I SPIRONOLACTONE

HYDROCHLOROTHIAZIDE; HYDROCHLOROTHIAZIDE; HYDROCORTISONE HYDROCORTISONE ACETATE

I HYDROCORTISot~E; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

I

HYDROCORTISONE ACETATE; NEOMYCINISULFATE HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE HYDROCORTISONE SODIUM SUCCINATE I HYDROXOCOBALAMIN HYDROXYZINE HYDROCHLORIDE I

HYDROXYZINE PAMOATE IBUPROFEN IMIPRAMINE HYDROCHLORIDE IODOXAMATE MEGLUMINE IOTHALAftoHE SODIU~l, 1-125

x

X X

x x I ' I X

X I I X I I X

X X

xl Ixi X IXIXIX X

X I X I I I X xl X X ~IXIXIX

X x

X I X x X

X ---------------------T-----------------------------r~--_r--f--_r--r--+---+--~--+-~---~

IRON DEXTRAN COMPLEX ISOETHARINE HYDROCHLORIDE

e ie X X I X x

8

e

• .' APPROVED PRESCRIPTION DRUG PRODUCTS -9 DRUG PRODUCT LIST CU~IULATIVE INDEX

INGREDIENT! S) SUPPLEMENT: 1 2 3 4 5 I 6 7 8 I 9 10 11 12 13

ISONIAZID X X I X X ISDSORBIDE X ISOSULFAN BLUE X KETOCONAlOLE X LEVOPROPOXYPHENE NAPSYLATE X

LIDOCAINE X LIDOCAINE HYDROCHLORIDE X X X LITHIUM CARBONATE X X X LITHIUM CITRATE X X X LORAZEPAM X

.-MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM

I CHLORIDE; SODIUM GLUCONATE X N.o.NNITOL X MANNITOL; SORBITOL X MAPROTILINE HYDROCHLORIDE X ~IAZH1DOL X

I -- -NECLIZINE HYDROCHLORIDE X NECLOCYCLINE SULFOSALICYLATE X MEPERIDINE HYDROCHLORIDE X X NEFROBA~IATE X

I

X X METAPROTERENOL SULFATE X

-METHADONE HYDROCHLORIDE X NETHAQUALOI~E X NETHDILAZINE HYDROCHLORIDE X METHOXSALEN X METHYlDOPA X

.-

METHYLPREDNISOLONE X METHYLPREDNISOLONE; NEOMYCIN SULFATE X METHYLPREDNISOLONE ACETATE X METHYLFREDNISOLONE SODIUM SUCCINATE X METHYLTESTOSTERONE X X X

METOCLOPRMIIDE HYDROCHLORIDE X ~IETO LAZONE X METRONIDAZOLE HYDROCHLORIDE X MICONAZOLE NITRATE X MOLINDONE HYDROCHLORIDE X

NADOLOL X NAPROXEN SODIU11 X NEOMYCIN SULFATE; PREDNISOLONE X X NEOMYCIN SULFATE; PREDNISOLONE ACETATE X NEmlYCIN SULFATE; PREDNISOLONE SODIUt1 PHOSPHATE X

I

-f---NEOSTIGMINE BROMIDE X

INGREDIENT(S)

NITROFURAZONE NORETHINDRONE NOVOBIOCIN CALCIUM NOVOBIOCIN SODIUM ORPHENADRINE CITRATE

OXACILLIN SODIUM NONOHYDRATE OXYTOCIN OXYTOCIN CITRATE PENICILLIN G POTASSIUM PENICILLIN G PROCAINE

PENICILLIN G SODIUM PENICILLIN V POTASSIUM PENTOBARBITAL SODIUM PHENDIt1ETRAZINE TARTRATE PHENTERMINE HYDROCHLORIDE

PHENYTOIN SODIUM POTASSIUt1 CHLORIDE PRAZEPAM PREDNISOLONE PREDNISOLONE ACETATE

I

I

!

I

I

I

I I

I

APPROVED PRESCRIPTION DRUG PRODUCTS DRUG PRODUCT LIST CU~lULATIVE IlmEX

SUPPLEMENT: 1 2

X X

X X

X

X

X X X

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM X PREDNISOLONE SODIUM PHOSPHATE i PREDNIsmlE PROCAINAMIDE HYDROCHLORIDE I PROCAINE HYDROCHLORIDE

I

PROMETHAZINE HYDROCHLORIDE PROPIOLACTONE PROPOXYPHENE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE

I PYRIDOXINE HYDROCHLORIDE X

QUINIDINE SULFATE RAUWOLFIA SERPENTINA RESERPINE RESERPINE; TRICHLORMETHIAZIDE X RITOORINE HYDROCHLORIDE X

ARALASIN ACETATE COPOLAmNE COPOLAMINE HYOROBROMIDE ECOBARBITAL SODIUM ECRETIN

ODIUM AMINOSALICYLATE X ODIUM CHLORIDE

e e

3 4

X

X X

X

X X

X

X X

10

5 6 7 8 9 110 11 12 13

X X X

X X

X

X

X X

X X X X

X X X I---

X X X

X X

X

X X X X X

j--+- -f--X X

X X X

X X

-I---j--- ---X X X

X

X -- j---

X

X X X X

-f---- -- f-- --f---

X

e

• APPROVED PRESCRIPTION DRUG PRODUCTS • l~ DRUG PRODUCT LIST CUMULATIVE INDEX

INGREDIENT! S) SUPPLEMENT: 1 2 3 4 5 6 7 '6 9 10 11 12 13

SOYBEAN OIL X SPIRONOLACTONE X X X SULF M1ETHIZOLE X SULFAMETHOXAZOLE X X SULFAMETHOXAZOLE; TRItlETHOPRIM X X

SULFASALAZINE X X X X SULFISOXAZOLE X X X X X X TECHNETIUt1, TC-99M, ETIDRONATE KIT X TECHNETIUM, TC-99M, MEDRONATE KIT X X TECHNETIUM, TC-99M, OXIDRONATE KIT X

TECHNETIUM, TC-991', PENTETATE KIT X TECHNETIUM, TC-99tt, PYROPHOSPHATE KIT X TEI'lAlEPp,M X TESTOSTERONE CYPIONATE X X TESTOSTEROIIE ENMlTHATE X X -----TETRACYCLINE HYDROCHLORIDE X THEOPHYLLINE X X X TOLBUTAmDE X X TRIAtlCINOLOtlE ACETONIDE X X TRIAtlCINOLOflE DIACETATE X X

TRICHLORMETHIAZIDE X X TRISULFAPYRIMIDINES X X X VERAPAMIL HYDROCHLORIDE X VITAMIN A X WATER, FOR INJECTION X

XYLOSE. O- X ZmlEPIRAC SODIUM X

:~~'h=

: .... ~::i:.

PRESCRIPTION DRUG PRODUCTS DEEMED APPROVED PENDING RESOLUTION OF SAFETY OR EFFECTIVENESS ISSUES

SUPPLEMENT NU~lBER 13

CURRENT STATUS ~ INEFFECTIVE

OXSORALEN INol-,/~,'I/-p#/ > ADD > ELDER PHARMS

- /,61;1r4~~

• • PRESCRIPTION DRUG PRODUCTS DEEMED APPROVED -13 PENDING RESOLUTION OF SAFETY OR EFFECTIVENESS ISSUES CUHULATIVE INDEX

TRADE NAME SUPPLEMENT: 1 2 3 4 5 6 7 8 9 10 11 12 13

ACHROMYCIN X BACITRACIN; NEOMYCIN; POLYMYXIN; HYDROCORTISONE ACETATE X BARBIDONNA X BARBIDONNA NO.2 X BENTYL WI PHENOBARBITAL X

BIOlYHE X I BUTIBEL X

CANTIL WI PHENOBARBITAL X I CHLOROMYCETIN HYDROCORTISONE X CLISTl,~ EXPECTORANT X

---

COR-OTICIN X CORTISPORIN X DACTIL X X DACTIL AND PHENOBARBITAL X X DARICON PB X

--DICYCLOHINE HCL X DIPYRIDAtlOLE X X DONNATAL X DYSPAS X FLORINEF-S X

---ISOSORBIDE DINITRATE

I

X LEVSIN PB X LEVSIN WI PHENOBARBITAL X LIBRAX X MEPROBA.t!ATE WI TRIDIHEXETHYL CHLORIDE X X

METI-DERM WI NEOMYCIN X I METIHYD X MILPATH-200 X MILPATH-400 X NEO-ARISTOCORT ACETON!DE X

I

I

e-----NEO-DELTA-CORTEF X NEO-DELTEF X NEO-MEDROL X NEOQUESS X X NEOSONE X

NITROGLYCERIN X X X NYSTATIN, NEOMYCIN SULFATE, GRAMICIDIN, TRIAl1CINOLONE ACETONIDE X OPfiTHOCORT X ORTHOXINE X

I OXSORALEN X

PARAFON FORTE X I PATHIBAMATE-200 X

-- ~rU&

L

TRA DE NAtlE

PAT PAT PHE PIT POL

PRE PRO PRO ROB ROB

SPA SUL T.C T.C TER

TRA

'1IBAm,TE-400 ,ILON WI PHENOBARBITAL ~OBARBITAL & BELLADONNA DCIN CITRATE Y-PRED

DMYCIN-P -BANT/UNE WI OARTAL -BANTHHlE WI PHENOBARBITAL INUL-PH INUL-PH FORTE

LIX FATHALIDINE .M. 200 .M. 400 RA-CORTRIL

L GRADUMET

PRESCRIPTION DRUG PRODUCTS DEEMED APPROVED PENDING RESOLUTION OF SAFETY OR EFFECTIVENESS ISSUES

CUMULATIVE INDEX

SUPPLEMENT: 1 2 3 4

X

X

X

X

v

14

5 6 7 8 9 10 11 12 13

X X

X X

X X , X X X X

X

X X

X I

J