FDA.reportPublic FDA data

Application 075704

Type
ANDA
Sponsor
MYLAN

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
0378-3020FamotidinefamotidineMylan Pharmaceuticals Inc.ANDACurrent
0378-3020FamotidinefamotidineMylan Pharmaceuticals IncANDACurrent
0378-3040FamotidinefamotidineMylan Pharmaceuticals IncANDACurrent
51079-966FamotidinefamotidineMylan Institutional Inc.ANDACurrent
51079-966FamotidinefamotidineMylan Institutional Inc.ANDACurrent
55154-5464FamotidinefamotidineCardinal HealthANDACurrent
67296-0183FamotidineFamotidineRedPharm Drug, Inc.ANDACurrent
67296-0183FamotidineFamotidineRedPharm Drug, Inc.ANDACurrent
70518-1089FamotidinefamotidineREMEDYREPACK INC.ANDACurrent
70518-1089FamotidinefamotidineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30993ORIG2004-06-04
30992ORIG2001-04-16