FOOD AND DRUGS ADMINISTRATION

PUDUCHERRY

Fixed Dose Combinations ( FDC ) Fixed Dose Combination (FDC) is a combination of two or more

pharmaceutically active ingredients to make a single dosage which is prescribed in a fixed dose. FDC improves the efficacy of a medicy of a medicine thus reducing the number of pills taken by the patient.

When two drugs combine, they become a new drug which require approval and license for manufacture. The license is approved by the State Drug Controller, and approval is provided by the Drug Controller General of India (DCGI).

Presently, 294 FDCs are pending for approval by the DCGI after the licenses were issued from State Drug Controller. Out of the 294 FDCs, 78 FDCs are liable to get approval by the DCGI under certain conditions. The list of those 78 FDCs is as given below:

S. No.

Name of FDC Category Remarks

1. Ibuprofen + Colchicine Orthopedics

2. Aloe extract + Allantocin + Alfa tocoferal acetate + D-panthemol + Vit A

Dermatologicals Should be Topical

3. Allantoin + Vit-E + Cammelina Sinensis Dermatologicals Should be Topical

4. Aloe extract + Vit-E + Dimethicone + Glycerine Dermatologicals Should be Topical

5. Aloe vera + jojoba oil + Vit-E Dermatologicals Should be Topical

6. Aloe vera + Orange oil Dermatologicals Should be Topical

7. Aloe vera + Vit-E acetate Dermatologicals Should be Topical

8. Aloe + tocopherol Dermatologicals Should be Topical

9. Aloe vera + Glycerine + PFG 100 stearate + Vit-E

Dermatologicals Should be Topical

10. Aloe vera + Jojoba Oil + Wheat germ oil + Tea tree oil

Dermatologicals Should be Topical

11. Aloe vera + Vit-E + Herbal Dermatologicals Should be Topical

12. Chlorzoxazone + Nimesulide Orthopaedics

13. Chlorzoxazone + Paracetamol Orthopaedics

14. Diclofenac + Tizanidine Orthopaedics

15. Drotaverine hydrochloride + Mefenamic acid Gastrointestinal

16. Drotaverine + Mefenamic acid Gastrointestinal

17. Drotaverine + Nimesulide Gastrointestinal

18. Ibuprofen + Dextropropoxyphene Orthopaedics

19. Ibuprofen + Tizanidine Orthopaedics

20. Mecobalaminalphalipoic Acid + Folic acid + Vit B6 + Choline

Nutritionals Doses of Vitamins should be as per Schedule V

21. Mecobalamine + Alpha lipoic acid Nutritionals Doses of Vitamins should be as per Schedule V

22. Mecobalamine + Alpha lipoic acid + Folic acid Nutritionals Doses of Vitamins should be as per Schedule V

23. Mecobalamine + Alpha lipoic acid + Vit B1 + Folic acid.

Nutritionals Doses of Vitamins should be as per Schedule V

24. Mecobalamine + Biotin Nutritionals Doses of Vitamins should be as per Schedule V

25. Mecobalamine + Calcium panothenate Nutritionals Doses of Vitamins should be as per Schedule V

26. Mecobalamine + Carotinoid + Alpha lipoic acid + Chromim + Vit B1 + Vit B Complex

Nutritionals Doses of Vitamins should be as per Schedule V

27. Mecobalamine + Folic acid Nutritionals Doses of Vitamins should be as per Schedule V

28. Mecobalamine + Methenamine mandelate Nutritionals Doses of Vitamins should be as per Schedule V

29. Mecobalamine + Vit-A + Vit-E + Vit-C + Vit-B1 + Vit-B6 + Vit-D3 + Selenium

Nutritionals Doses of Vitamins should be as per Schedule V

30. Mecobalamine +Vitamins + Minerals Nutritionals Doses of Vitamins should be as per Schedule V

31. Mecobalamine + Vit-B1 + Vit-B2 + Vit-B6 + Folic acid

Nutritionals Doses of Vitamins should be as per Schedule V

32. Mecobalamine + Vit-B1 + Vit-B6 + Folic acid + Alpha lipoic

Nutritionals Doses of Vitamins should be as per Schedule V

33. Mecobalamine + Vit-B1 + Vit-B6 + Nicotinamide + D-Panthenol

Nutritionals Doses of Vitamins should be as per Schedule V

34. Mecobalamine + Vit B6 + Folic acid Nutritionals Doses of Vitamins should be as per Schedule V

35. Acetylcysteine + Selenomethionone + choline Bitartrate + Pyridoxine + Folic Acid+Vitamin E + Cyanocobalmin + Chromium Nicotinate + Manganese Sulfate + Zinc Sulfate

Nutritionals Doses of Vitamins should be as per Schedule V

36. Acriflavine + Gentain violet + Brilliant green Dermatologicals Should be topical

37. Alendronate sodium + Calcium carbonate + Vit-D3

Orthopaedics

38. Allantoin + Triclosan + Vit-E + Zinc Oxide Dermatologicals Should be topical

39. Drotaverine + Paracetamol GI

40. Ibuprofen + Paracetamol + caffeine Cough & Cold

41. Ibuprofen + Pseudoephedrine + Chlorpheniramine

Cough & Cold

42. Metoclopramide hydrochloride + Paracetamol GI

43. Acetyl salicylic acid + Ethoheptazine Analgesics

44. Norfloxacin + Ornidazole GI

45. Ofloxacin + Tinidazole GI

46. Aceclofenac + Tramadol Orthopaedics

47. 5-bromosalicyl-4-chloranilide + salicylic acid Dermatologicals Should be topical

48. Ofloxacin + Prednisolone Opthalmic Should be opthalmic solution

49. Lansoprazole + Amoxycillin + Clarithromycin GI Should be combipack

50. Lansoprazole + Amoxycillin + Tinidazole GI Should be combipack

51. Lansoprazole + Tinidazole + Clarithromycin GI Should be combipack

52. Ornidazole + Flucanazole + Azithromycin Antimicrobial Should be combipack

53. Clinamycin + Clotrimazole + Metronidazole Dematologicals Should be topical

54. Mupirocin + Metronidazole Dematologicals Should be topical

55. Benfotimine + Pyridoxine + Mecobalamine +

Inositol + Alphalipoic acid

Nutritionals Doses of Vitamins should be as per schedule V

56. Amoxycillin + Clavulanic acid + Lactic acid bacillus

Antimicrobial Dose of lactobacillus should be 5 billion per day

57. Amoxycillin + Clavulanic acid + Lactobacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

58. Amoxycillin + Lactic acid bacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

59. Amoxycillin + Lactobacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

60. Amoxycillin + Lactobacillus acidophilus Antimicrobial Dose of lactobacillus should be 5 billion per day

61. Amoxycillin + Lactobacillus acidophilus + Clavulanic acid

Antimicrobial Dose of lactobacillus should be 5 billion per day

62. Ampicillin + Lactic acid bacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

63. Cefadroxyl + Lactic acid bacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

64. Cefdinir + Lactic acid bacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

65. Cefixime + Lactic acid bacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

66. Cefixime + Lactobacillus acidophilus Antimicrobial Dose of lactobacillus should be 5 billion per day

67. Cefixime + Lactobacillus acvidophilus Antimicrobial Dose of lactobacillus should be 5 billion per day

68. Cefpodoximeprozetil + Lactic acid bacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

69. Cefpodoxime + Lactic acid bacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

70. Cefpodoxime + Lactobacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

71. Cefprozil + Lactobacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

72. Doxycycline + Lactobacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

73. Lincomycin + Lactobacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

74. AmoxicillinCloxacillin + Lactic acid bacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

75. Amoxicillin + Cloxacillin + Lactic acid bacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

76. Amoxicillin + Cloxacillin + Lacto acid bacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

77. Ampicillin + Cloxacillin + Lactic acid bacillus Antimicrobial Dose of lactobacillus should be 5 billion per day

78. Cefixime + Lactobacillus + Clavulanic acid Antimicrobial Dose of lactobacillus should be 5 billion per day