FDA.reportPublic FDA data

Application 075714

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBAMAZEPINECARBAMAZEPINESUSPENSION;ORAL100MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0862CarbamazepineCarbamazepinePharmaceutical Associates, Inc.ANDACurrent
0121-0862CarbamazepineCarbamazepinePharmaceutical Associates, Inc.ANDACurrent
0121-0862CarbamazepineCarbamazepinePharmaceutical Associates, Inc.ANDACurrent
0121-0862CarbamazepineCarbamazepinePharmaceutical Associates, Inc.ANDACurrent
0121-0862CarbamazepineCarbamazepinePAI Holdings, LLCANDACurrent
0121-1724CarbamazepineCarbamazepinePAI Holdings, LLCANDACurrent
0121-1724CarbamazepineCarbamazepinePharmaceutical Associates, Inc.ANDACurrent
0121-1724CarbamazepineCarbamazepinePharmaceutical Associates, Inc.ANDACurrent
0121-1724CarbamazepineCarbamazepinePharmaceutical Associates, Inc.ANDACurrent
0121-1724CarbamazepineCarbamazepinePharmaceutical Associates, Inc.ANDACurrent
17856-0029CARBAMAZEPINEcarbamazepineATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0029CARBAMAZEPINEcarbamazepineATLANTIC BIOLOGICALS CORP.ANDACurrent
60432-129CARBAMAZEPINEcarbamazepineMorton Grove Pharmaceuticals, Inc.ANDACurrent
68094-007CarbamazepineCarbamazepinePrecision Dose, Inc.ANDACurrent
68094-007CarbamazepineCarbamazepinePrecision Dose, Inc.ANDACurrent
68094-007CarbamazepineCarbamazepinePrecision Dose, Inc.ANDACurrent
68094-007CarbamazepineCarbamazepinePrecision Dose, Inc.ANDACurrent
68094-008CarbamazepineCarbamazepinePrecision Dose, Inc.ANDACurrent
68094-008CarbamazepineCarbamazepinePrecision Dose, Inc.ANDACurrent
68094-008CarbamazepineCarbamazepinePrecision Dose, Inc.ANDACurrent
68094-008CarbamazepineCarbamazepinePrecision Dose, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24156ORIG2008-02-01