FDA.reportPublic FDA data

Application 203020

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRBESARTANIRBESARTANTABLET;ORAL75MGNoNo
002IRBESARTANIRBESARTANTABLET;ORAL150MGNoNo
003IRBESARTANIRBESARTANTABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-212IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-212IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-212IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-212IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-212IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-212IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-213IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-213IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-213IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-213IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-213IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-213IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-214IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-214IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-214IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-214IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-214IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-214IrbesartanIrbesartanUnichem Pharmaceuticals (USA), Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10146ORIG2015-12-09