FDA.reportPublic FDA data

Application 207018

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;150MGNoNo
002IRBESARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; IRBESARTANTABLET;ORAL12.5MG;300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-215Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-215Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-215Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-215Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-215Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-215Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-215Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-216Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-216Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-216Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-216Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-216Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-216Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-216Irbesartan and HydrochlorothiazideIrbesartan and HydrochlorothiazideUnichem Pharmaceuticals (USA), Inc.ANDACurrent