FDA.reportPublic FDA data

Application 207446

Type
ANDA
Sponsor
CIPLA

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
16714-731CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-731CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-731CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-732CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-732CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-732CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-733CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-733CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-733CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-734CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-734CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
16714-734CELECOXIBCELECOXIBNorthStar RxLLCANDACurrent
43063-669CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-669CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-669CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-669CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-669CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-669CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2394CELECOXIBCELECOXIBA-S Medication SolutionsANDACurrent
55700-449CELECOXIBCELECOXIBLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-450CELECOXIBCELECOXIBLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-301CELECOXIBCELECOXIBProficient Rx LPANDACurrent
63187-301CELECOXIBCELECOXIBProficient Rx LPANDACurrent
67296-1345CELECOXIBCELECOXIBRedPharm Drug, Inc.ANDACurrent
67296-1345CELECOXIBCELECOXIBRedPharm Drug, Inc.ANDACurrent
67296-1345CELECOXIBCELECOXIBRedPharm Drug, Inc.ANDACurrent
68788-6393CELECOXIBCELECOXIBPreferred Pharmaceuticals Inc.ANDACurrent
69097-420CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-420CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-420CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-420CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-420CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-420CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-421CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-421CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-421CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-421CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-421CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-421CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-422CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-422CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-422CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-422CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-422CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-422CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-423CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-423CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-423CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-423CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-423CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
69097-423CELECOXIBCELECOXIBCipla USA Inc.ANDACurrent
70518-2233CELECOXIBCELECOXIBREMEDYREPACK INC.ANDACurrent
70934-978CELECOXIBCELECOXIBDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-978CELECOXIBCELECOXIBDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0450CELECOXIBCELECOXIBBryant Ranch PrepackANDACurrent
76282-692CELECOXIBCELECOXIBExelan Pharmaceuticals, IncANDACurrent
76282-693CELECOXIBCELECOXIBExelan Pharmaceuticals, IncANDACurrent
76282-694CELECOXIBCELECOXIBExelan Pharmaceuticals, IncANDACurrent
76282-695CELECOXIBCELECOXIBExelan Pharmaceuticals, IncANDACurrent
80425-0039CelebrexCelecoxib 200mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0039CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0039CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0142CelebrexCelecoxib 100mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0142CelebrexCelecoxib 100mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0142CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0142CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0142CelecoxibCelecoxibAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent