FDA.reportPublic FDA data

Application 210071

Type
ANDA
Sponsor
CSPC OUYI

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69367-301CelecoxibCelecoxibWestminster Pharmaceuticals, LLCANDACurrent
69367-301CelecoxibCelecoxibWestminster PharmaceuticalsANDACurrent
69367-301CelecoxibCelecoxibWestminster Pharmaceuticals, LLCANDACurrent
69367-301CelecoxibCelecoxibWestminster Pharmaceuticals, LLCANDACurrent
69367-302CelecoxibCelecoxibWestminster Pharmaceuticals, LLCANDACurrent
69367-302CelecoxibCelecoxibWestminster PharmaceuticalsANDACurrent
69367-302CelecoxibCelecoxibWestminster Pharmaceuticals, LLCANDACurrent
69367-302CelecoxibCelecoxibWestminster Pharmaceuticals, LLCANDACurrent
71626-301CelecoxibCelecoxibMedstone Pharma LLCANDACurrent
71626-301CelecoxibCelecoxibMedstone Pharma LLCANDACurrent
71626-302CelecoxibCelecoxibMedstone Pharma LLCANDACurrent
71626-302CelecoxibCelecoxibMedstone Pharma LLCANDACurrent
71626-303CelecoxibCelecoxibMedstone Pharma LLCANDACurrent
71626-303CelecoxibCelecoxibMedstone Pharma LLCANDACurrent
80425-0209CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent