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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: ANDA 040620 BIOEQUIVALENCE REVIEWS

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Page 1: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

ANDA 040620

BIOEQUIVALENCE REVIEWS

Page 2: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 3: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 4: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 5: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 6: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 7: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 8: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 9: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 10: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 11: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 12: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 13: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 14: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 15: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 16: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 17: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 18: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 19: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 20: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 21: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 22: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 23: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 24: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 25: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 26: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 27: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 28: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 29: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 30: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 31: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 32: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 33: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 34: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 35: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 36: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 37: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 38: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 39: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 40: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 41: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 42: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 43: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 44: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 45: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 46: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 47: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 48: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 49: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 50: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 51: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 52: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 53: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 54: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 55: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 56: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 57: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 58: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 59: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 60: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 61: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 62: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 63: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 64: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 65: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 66: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 67: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 68: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 69: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 70: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 71: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 72: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 73: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 74: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 75: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 76: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 77: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 78: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 79: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 80: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 81: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 82: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 83: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 84: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 85: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 86: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 87: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 88: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 89: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 90: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 91: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 92: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24
Page 93: APPLICATION NUMBER: ANDA 040620 › drugsatfda_docs › ... · The test and reference formulations are identical, for both 40 mg/mL and 80 mg/mL, as shown in the Appendix, page 24

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METHOTREXATE INJECTION, USP - Accord Healthcare · methotrexate injection, usp 50 mg/2 ml (25 mg/ml), 250 mg/10 ml (25 mg/ml) and 1 g/40 ml (25 mg/ml) (preservative free) warnings:

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EPTIFIBATIDE - Slate Run Pharmaceuticals...EPTIFIBATIDE INJECTION PRODUCT DETAILS • Concentration: Available in 2 mg per mL (20 mg/10 mL) or 0.75 mg per mL (75 mg/100 mL) • Fill

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