FDA.report

Application 075805

Type
ANDA
Sponsor
CARLSBAD

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001FAMOTIDINEFAMOTIDINETABLET;ORAL20MGNoNo
002FAMOTIDINEFAMOTIDINETABLET;ORAL40MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-4420PepcidfamotidineBausch Health US LLCANDACurrent
0187-4420PepcidfamotidineBausch Health Americas Inc.ANDACurrent
0187-4420PepcidfamotidineValeant Pharmaceuticals North America LLCANDACurrent
0187-4440PepcidfamotidineBausch Health US LLCANDACurrent
0187-4440PepcidfamotidineBausch Health Americas Inc.ANDACurrent
0187-4440PepcidfamotidineValeant Pharmaceuticals North America LLCANDACurrent
10544-481FamotidineFamotidineBlenheim Pharmacal, Inc.ANDACurrent
33261-185FamotidineFamotidineAidarex Pharmaceuticals LLCANDACurrent
42291-281FamotidineFamotidineAvKARE, Inc.ANDACurrent
42291-281FamotidineFamotidineAvKAREANDACurrent
42291-282FamotidineFamotidineAvKARE, Inc.ANDACurrent
42291-282FamotidineFamotidineAvKAREANDACurrent
43063-695FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-695FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-695FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-695FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-695FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-695FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-695FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-695FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-695FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-696FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-696FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-696FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-696FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-696FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-696FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-696FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-696FamotidineFamotidinePD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-230FamotidineFamotidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-230FamotidineFamotidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-230FamotidineFamotidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-237FamotidineFamotidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
49999-237FamotidineFamotidineLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-1045FamotidineFamotidineA-S Medication SolutionsANDACurrent
50090-1045FamotidineFamotidineA-S Medication SolutionsANDACurrent
50090-1045FamotidineFamotidineA-S Medication SolutionsANDACurrent
50090-1045FamotidineFamotidineA-S Medication SolutionsANDACurrent
50090-1432FamotidineFamotidineA-S Medication SolutionsANDACurrent
50090-1432FamotidineFamotidineA-S Medication SolutionsANDACurrent
50090-1432FamotidineFamotidineA-S Medication SolutionsANDACurrent
50090-1432FamotidineFamotidineA-S Medication SolutionsANDACurrent
50090-1432FamotidineFamotidineA-S Medication SolutionsANDACurrent
50090-2905FamotidineFamotidineA-S Medication SolutionsANDACurrent
50268-303FamotidineFamotidineAvPAKANDACurrent
50268-303FamotidineFamotidineAvPAKANDACurrent
50268-304FamotidineFamotidineAvPAKANDACurrent
50268-304FamotidineFamotidineAvPAKANDACurrent
50436-7371FamotidineFamotidineUnit Dose ServicesANDACurrent
51655-312FamotidineFamotidineNorthwind PharmaceuticalsANDACurrent
51655-312FamotidineFamotidineNorthwind PharmaceuticalsANDACurrent
52959-116FamotidineFamotidineH.J. Harkins Company, Inc.ANDACurrent
53002-3199FamotidineFamotidineRPK Pharmaceuticals, Inc.ANDACurrent
55154-6843FamotidineFamotidineCardinal Health 107, LLCANDACurrent
55154-6843FamotidineFamotidineCardinal HealthANDACurrent
55154-6843FamotidineFamotidineCardinal HealthANDACurrent
55154-6843FamotidineFamotidineCardinal HealthANDACurrent
60429-721FamotidineFamotidineGolden State Medical Supply, Inc.ANDACurrent
60429-721FamotidineFamotidineGolden State Medical Supply, Inc.ANDACurrent
60760-327FamotidineFamotidineSt. Mary's Medical Park PharmacyANDACurrent
60760-327FamotidineFamotidineSt. Mary's Medical Park PharmacyANDACurrent
60760-327FamotidineFamotidineSt. Mary's Medical Park PharmacyANDACurrent
61442-121FamotidineFamotidineCarlsbad Technology, IncANDACurrent
61442-121FamotidineFamotidineCarlsbad Technology, IncANDACurrent
61442-122FamotidineFamotidineCarlsbad Technology, IncANDACurrent
61442-122FamotidineFamotidineCarlsbad Technology, IncANDACurrent
61919-281FAMOTIDINEFAMOTIDINEDirect RxANDACurrent
61919-281FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
61919-281FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
61919-281FAMOTIDINEFAMOTIDINEDirect RxANDACurrent
61919-281FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
61919-281FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
61919-281FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
61919-281FAMOTIDINEFAMOTIDINEDirect_RxANDACurrent
63187-129FamotidineFamotidineProficient Rx LPANDACurrent
63187-129FamotidineFamotidineProficient Rx LPANDACurrent
63187-129FamotidineFamotidineProficient Rx LPANDACurrent
63629-1013FamotidineFamotidineBryant Ranch PrepackANDACurrent
63629-1013FamotidineFamotidineBryant Ranch PrepackANDACurrent
63629-1013FamotidineFamotidineBryant Ranch PrepackANDACurrent

Documents

DocumentSubmission typeDate
31021ORIG2001-04-16