FDA.reportPublic FDA data

Application 090763

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LANSOPRAZOLELANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL15MGNoNo
002LANSOPRAZOLELANSOPRAZOLECAPSULE, DELAYED REL PELLETS;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-8015LansoprazolelansoprazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-8015LansoprazolelansoprazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-8015LansoprazolelansoprazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-8015LansoprazolelansoprazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-8030LansoprazolelansoprazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-8030LansoprazolelansoprazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-8030LansoprazolelansoprazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-8030LansoprazolelansoprazoleMylan Pharmaceuticals Inc.ANDACurrent
51079-121LansoprazolelansoprazoleMylan Institutional Inc.ANDACurrent
51079-121LansoprazolelansoprazoleMylan Institutional Inc.ANDACurrent
51079-121LansoprazolelansoprazoleMylan Institutional Inc.ANDACurrent
68788-9269LansoprazolelansoprazolePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31492ORIG2009-11-19