FDA.reportPublic FDA data

Application 207872

Type
ANDA
Sponsor
TIANJIN TIANYAO

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
42806-720CelecoxibCelecoxibEPIC PHARMA, LLCANDACurrent
42806-720CelecoxibCelecoxibEPIC PHARMA, LLCANDACurrent
42806-721CelecoxibCelecoxibEPIC PHARMA, LLCANDACurrent
42806-721CelecoxibCelecoxibEPIC PHARMA, LLCANDACurrent
42806-722CelecoxibCelecoxibEPIC PHARMA, LLCANDACurrent
42806-722CelecoxibCelecoxibEPIC PHARMA, LLCANDACurrent
42806-723CelecoxibCelecoxibEPIC PHARMA, LLCANDACurrent
42806-723CelecoxibCelecoxibEPIC PHARMA, LLCANDACurrent
57582-211CelecoxibCelecoxibTianjin Tianyao Pharmaceuticals Co., Ltd.ANDACurrent
57582-211CelecoxibCelecoxibTianjin Tianyao Pharmaceuticals Co., Ltd.ANDACurrent
57582-211CelecoxibCelecoxibTianjin Tianyao Pharmaceuticals Co., Ltd.ANDACurrent
57582-212CelecoxibCelecoxibTianjin Tianyao Pharmaceuticals Co., Ltd.ANDACurrent
57582-212CelecoxibCelecoxibTianjin Tianyao Pharmaceuticals Co., Ltd.ANDACurrent
57582-212CelecoxibCelecoxibTianjin Tianyao Pharmaceuticals Co., Ltd.ANDACurrent
57582-213CelecoxibCelecoxibTianjin Tianyao Pharmaceuticals Co., Ltd.ANDACurrent
57582-213CelecoxibCelecoxibTianjin Tianyao Pharmaceuticals Co., Ltd.ANDACurrent
57582-213CelecoxibCelecoxibTianjin Tianyao Pharmaceuticals Co., Ltd.ANDACurrent
57582-214CelecoxibCelecoxibTianjin Tianyao Pharmaceuticals Co., Ltd.ANDACurrent
57582-214CelecoxibCelecoxibTianjin Tianyao Pharmaceuticals Co., Ltd.ANDACurrent
57582-214CelecoxibCelecoxibTianjin Tianyao Pharmaceuticals Co., Ltd.ANDACurrent