FDA.reportPublic FDA data

Application 077255

Type
ANDA
Sponsor
TEVA PHARMS

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
0093-7350LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7350LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7350LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7350LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7350LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7350LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7350LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7351LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7351LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7351LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7351LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7351LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7351LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7351LansoprazoleLansoprazoleTeva Pharmaceuticals USA, Inc.ANDACurrent
42254-227LansoprazoleLansoprazoleRebel Distributors CorpANDACurrent
42291-364LansoprazoleLansoprazoleAvKARE, Inc.ANDACurrent
42291-364LansoprazoleLansoprazoleAvKAREANDACurrent
42291-365LansoprazoleLansoprazoleAvKARE, Inc.ANDACurrent
42291-365LansoprazoleLansoprazoleAvKAREANDACurrent
50436-7350LansoprazoleLansoprazoleUnit Dose ServicesANDACurrent
63187-152LansoprazoleLansoprazoleProficient Rx LPANDACurrent
63187-152LansoprazoleLansoprazoleProficient Rx LPANDACurrent
68788-9677LansoprazoleLansoprazolePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31211ORIG2009-11-13