FDA.report

Application 078916

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001FAMOTIDINEFAMOTIDINETABLET;ORAL20MGNoNo
002FAMOTIDINEFAMOTIDINETABLET;ORAL40MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-293FamotidineFamotidineAlembic Pharmaceuticals LimitedANDACurrent
46708-293FamotidineFamotidineAlembic Pharmaceuticals LimitedANDACurrent
46708-294FamotidineFamotidineAlembic Pharmaceuticals LimitedANDACurrent
46708-294FamotidineFamotidineAlembic Pharmaceuticals LimitedANDACurrent
50436-1000FamotidineFamotidineUnit Dose ServicesANDACurrent
53002-1199FamotidineFamotidineRPK Pharmaceuticals, Inc.ANDACurrent
53002-1199FamotidineFamotidineRPK Pharmaceuticals, Inc.ANDACurrent
60760-070FamotidineFamotidineSt. Mary's Medical Park PharmacyANDACurrent
60760-070FamotidineFamotidineSt. Mary's Medical Park PharmacyANDACurrent
61919-236FAMOTIDINEFAMOTIDINEDIRECT RXANDACurrent
61919-236FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
61919-236FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
61919-236FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
61919-236FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
61919-236FAMOTIDINEFAMOTIDINEDIRECT RXANDACurrent
62332-001FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-001FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-001FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-001FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-001FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-002FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-002FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-002FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-002FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
62332-002FamotidineFamotidineAlembic Pharmaceuticals Inc.ANDACurrent
63187-723FamotidineFamotidineProficient Rx LPANDACurrent
63187-723FamotidineFamotidineProficient Rx LPANDACurrent
63187-723FamotidineFamotidineProficient Rx LPANDACurrent
63187-723FamotidineFamotidineProficient Rx LPANDACurrent
63187-908FamotidineFamotidineProficient Rx LPANDACurrent
63187-908FamotidineFamotidineProficient Rx LPANDACurrent
63629-7926FamotidineFamotidineBryant Ranch PrepackANDACurrent
63629-7926FamotidineFamotidineBryant Ranch PrepackANDACurrent
63629-7926FamotidineFamotidineBryant Ranch PrepackANDACurrent
66267-543FamotidineFamotidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-543FamotidineFamotidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-648FamotidineFamotidineNuCare Pharmaceuticals, Inc.ANDACurrent
66267-648FamotidineFamotidineNuCare Pharmaceuticals, Inc.ANDACurrent
67046-412FamotidineFamotidineCoupler EnterprisesANDACurrent
67296-1383FamotidineFamotidineRedPharm Drug, Inc.ANDACurrent
67296-1383FamotidineFamotidineRedPharm Drug, Inc.ANDACurrent
67296-1383FamotidineFamotidineRedPharm Drug, Inc.ANDACurrent
68001-240FamotidineFamotidineBluePoint LaboratoriesANDACurrent
68001-240FamotidineFamotidineBluePoint LaboratoriesANDACurrent
68001-241FamotidineFamotidineBluePoint LaboratoriesANDACurrent
68001-241FamotidineFamotidineBluePoint LaboratoriesANDACurrent
68071-3201FamotidineFamotidineNuCare Pharmaceuticals, IANDACurrent
68071-3201FamotidineFamotidineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3201FamotidineFamotidineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3305FamotidineFamotidineNuCare Pharmaceutical, Inc.ANDACurrent
68071-3305FamotidineFamotidineNuCare Pharmaceutical, Inc.ANDACurrent
68071-3305FamotidineFamotidineNuCare Pharmaceutical, Inc.ANDACurrent
68788-6859FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-6859FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-6859FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-6859FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-6859FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7191FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7191FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7191FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7191FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7191FamotidineFamotidinePreferred Pharmaceuticals Inc.ANDACurrent
70518-2469FamotidineFamotidineREMEDYREPACK INC.ANDACurrent
70934-540FamotidineFamotidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-540FamotidineFamotidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-540FamotidineFamotidineDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-553FamotidineFamotidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-553FamotidineFamotidineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0231FamotidineFamotidineBryant Ranch PrepackANDACurrent
71335-0231FamotidineFamotidineBryant Ranch PrepackANDACurrent
71335-0409FamotidineFamotidineBryant Ranch PrepackANDACurrent
71335-0409FamotidineFamotidineBryant Ranch PrepackANDACurrent
71335-0409FamotidineFamotidineBryant Ranch PrepackANDACurrent
71610-399FamotidineFamotidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-399FamotidineFamotidineAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-141FAMOTIDINEFAMOTIDINEdirect rxANDACurrent
72189-141FAMOTIDINEFAMOTIDINEdirect rxANDACurrent