FDA.reportPublic FDA data

Application 075786

Type
ANDA
Sponsor
CELLTRION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAMOTIDINEFAMOTIDINETABLET;ORAL20MGNoNo
002FAMOTIDINEFAMOTIDINETABLET;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-562FamotidineFamotidineAidarex Pharmaceuticals LLCANDACurrent
55648-936FamotidineFamotidineWockhardt LimitedANDACurrent
55648-937FamotidineFamotidineWockhardt LimitedANDACurrent
64679-936FamotidineFamotidineWockhardt USA LLC.ANDACurrent
64679-937FamotidineFamotidineWockhardt USA LLC.ANDACurrent
68151-0185FamotidineFamotidineCarilion Materials ManagementANDACurrent
68788-9549FamotidineFamotidinePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9779FamotidineFamotidinePreferred Pharmaceuticals, Inc.ANDACurrent
72606-509FamotidineFamotidineCELLTRION USA, INC.ANDACurrent
72606-509FamotidineFamotidineCELLTRION USA, INC.ANDACurrent
72606-510FamotidineFamotidineCELLTRION USA, INC.ANDACurrent
72606-510FamotidineFamotidineCELLTRION USA, INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31017ORIG2004-06-04
8788ORIG2001-04-16