FDA.reportPublic FDA data

Application 079067

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METRONIDAZOLEMETRONIDAZOLETABLET;ORAL250MGNoNo
002METRONIDAZOLEMETRONIDAZOLETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-428MetronidazoleMetronidazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-428MetronidazoleMetronidazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-429MetronidazoleMetronidazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-429MetronidazoleMetronidazoleAlembic Pharmaceuticals LimitedANDACurrent
50268-534MetronidazoleMetronidazoleAvPAKANDACurrent
50268-534MetronidazoleMetronidazoleAvPAKANDACurrent
50268-534MetronidazoleMetronidazoleAvPAKANDACurrent
50268-534MetronidazoleMetronidazoleAvPAKANDACurrent
50268-535MetronidazoleMetronidazoleAvPAKANDACurrent
50268-535MetronidazoleMetronidazoleAvPAKANDACurrent
50268-535MetronidazoleMetronidazoleAvPAKANDACurrent
50268-535MetronidazoleMetronidazoleAvPAKANDACurrent
51655-123MetronidazoleMetronidazoleNorthwind PharmaceuticalsANDACurrent
51655-190MetronidazoleMetronidazoleNorthwind PharmaceuticalsANDACurrent
61919-385METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-385METRONIDAZOLEMETRONIDAZOLEDIRECT RXANDACurrent
61919-788MetronidazoleMetronidazoleDirect RxANDACurrent
61919-788MetronidazoleMetronidazoleDirect RxANDACurrent
62332-016MetronidazoleMetronidazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-016MetronidazoleMetronidazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-016MetronidazoleMetronidazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-016MetronidazoleMetronidazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-017MetronidazoleMetronidazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-017MetronidazoleMetronidazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-017MetronidazoleMetronidazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-017MetronidazoleMetronidazoleAlembic Pharmaceuticals Inc.ANDACurrent
63187-711MetronidazoleMetronidazoleProficient Rx LPANDACurrent
66267-147MetronidazoleMetronidazoleNuCare Pharmaceuticlas, Inc.ANDACurrent
66267-147MetronidazoleMetronidazoleNuCare Pharmaceuticlas, Inc.ANDACurrent
66267-148MetronidazoleMetronidazoleNuCare Pharmaceuticals, Inc.ANDACurrent
66267-148MetronidazoleMetronidazoleNuCare Pharmaceuticals, Inc.ANDACurrent
66267-804MetronidazoleMetronidazoleNuCare Pharmaceuticals, Inc.ANDACurrent
66267-804MetronidazoleMetronidazoleNuCare Pharmaceuticals, Inc.ANDACurrent
66267-804MetronidazoleMetronidazoleNuCare Pharmaceuticals, Inc.ANDACurrent
66267-805MetronidazoleMetronidazoleNuCare Pharmaceuticals, Inc.ANDACurrent
66267-805MetronidazoleMetronidazoleNuCare Pharmaceuticals, Inc.ANDACurrent
68071-2288MetronidazoleMetronidazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2288MetronidazoleMetronidazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5073MetronidazoleMetronidazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5073MetronidazoleMetronidazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7557MetronidazoleMetronidazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7557MetronidazoleMetronidazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9372MetronidazoleMetronidazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9397MetronidazoleMetronidazolePreferred Pharmaceuticals, Inc.ANDACurrent
71335-1681MetronidazoleMetronidazoleBryant Ranch PrepackANDACurrent
71335-1681MetronidazoleMetronidazoleBryant Ranch PrepackANDACurrent
72789-007MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-007MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-007MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-007MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-007MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-007MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-007MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-011MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-011MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-011MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-011MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-011MetronidazoleMetronidazolePD-Rx Pharmaceuticals, Inc.ANDACurrent