FDA.reportPublic FDA data

Application 213301

Type
ANDA
Sponsor
UNICHEM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CELECOXIBCELECOXIBCAPSULE;ORAL50MGNoNo
002CELECOXIBCELECOXIBCAPSULE;ORAL100MGNoNo
003CELECOXIBCELECOXIBCAPSULE;ORAL200MGNoNo
004CELECOXIBCELECOXIBCAPSULE;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-157CelecoxibCelecoxibUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-157CelecoxibCelecoxibUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-157CelecoxibCelecoxibUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-158CelecoxibCelecoxibUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-158CelecoxibCelecoxibUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-158CelecoxibCelecoxibUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-373CelecoxibCelecoxibUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-373CelecoxibCelecoxibUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-373CelecoxibCelecoxibUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-374CelecoxibCelecoxibUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-374CelecoxibCelecoxibUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-374CelecoxibCelecoxibUnichem Pharmaceuticals (USA), Inc.ANDACurrent