FDA.reportPublic FDA data

Application 204197

Type
ANDA
Sponsor
APOTEX INC

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
0904-6502CelecoxibCelecoxibMajor PharmaceuticalsANDACurrent
0904-6502CelecoxibCelecoxibMajor PharmaceuticalsANDACurrent
0904-6502CelecoxibCelecoxibMajor PharmaceuticalsANDACurrent
0904-6502CelecoxibCelecoxibMajor PharmaceuticalsANDACurrent
0904-6503CelecoxibCelecoxibMajor PharmaceuticalsANDACurrent
0904-6503CelecoxibCelecoxibMajor PharmaceuticalsANDACurrent
0904-6503CelecoxibCelecoxibMajor PharmaceuticalsANDACurrent
0904-6503CelecoxibCelecoxibMajor PharmaceuticalsANDACurrent
10544-953CelecoxibCelecoxibBlenheim Pharmacal, Inc.ANDACurrent
33358-902CelecoxibCelecoxibRxChange Co.ANDACurrent
43063-825CelecoxibCelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-825CelecoxibCelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-825CelecoxibCelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-825CelecoxibCelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-825CelecoxibCelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-5178CelecoxibCelecoxibA-S Medication SolutionsANDACurrent
50090-5178CelecoxibCelecoxibA-S Medication SolutionsANDACurrent
50436-3849CelecoxibCelecoxibUnit Dose ServicesANDACurrent
55154-7645CelecoxibCelecoxibCardinal Health 107, LLCANDACurrent
55154-7645CelecoxibCelecoxibCardinal HealthANDACurrent
55154-7645CelecoxibCelecoxibCardinal HealthANDACurrent
55154-7645CelecoxibCelecoxibCardinal HealthANDACurrent
55154-7646CelecoxibCelecoxibCardinal Health 107, LLCANDACurrent
55154-7646CelecoxibCelecoxibCardinal HealthANDACurrent
55154-7646CelecoxibCelecoxibCardinal HealthANDACurrent
55154-7646CelecoxibCelecoxibCardinal HealthANDACurrent
60505-3847CelecoxibCelecoxibApotex Corp.ANDACurrent
60505-3847CelecoxibCelecoxibApotex Corp.ANDACurrent
60505-3847CelecoxibCelecoxibApotex Corp.ANDACurrent
60505-3847CelecoxibCelecoxibApotex Corp.ANDACurrent
60505-3848CelecoxibCelecoxibApotex Corp.ANDACurrent
60505-3848CelecoxibCelecoxibApotex Corp.ANDACurrent
60505-3848CelecoxibCelecoxibApotex Corp.ANDACurrent
60505-3848CelecoxibCelecoxibApotex Corp.ANDACurrent
60505-3849CelecoxibCelecoxibApotex Corp.ANDACurrent
60505-3849CelecoxibCelecoxibApotex Corp.ANDACurrent
60505-3849CelecoxibCelecoxibApotex Corp.ANDACurrent
60505-3849CelecoxibCelecoxibApotex Corp.ANDACurrent
60760-209CelecoxibCelecoxibSt. Mary's Medical Park PharmacyANDACurrent
60760-209CelecoxibCelecoxibSt. Mary's Medical Park PharmacyANDACurrent
60760-849CelecoxibCelecoxibSt. Mary's Medical Park PharmacyANDACurrent
60760-849CelecoxibCelecoxibSt. Mary's Medical Park PharmacyANDACurrent
61919-043CELECOXIBCELECOXIBDirect_RxANDACurrent
61919-360CELECOXIBCELECOXIBDirect_RxANDACurrent
61919-360CELECOXIBCELECOXIBDirect_RxANDACurrent
61919-360CELECOXIBCELECOXIBDirect_RxANDACurrent
61919-360CELECOXIBCELECOXIBDirect_RxANDACurrent
61919-360CELECOXIBCELECOXIBDIRECT RXANDACurrent
61919-360CELECOXIBCELECOXIBDIRECT RXANDACurrent
61919-360CELECOXIBCELECOXIBDIRECT RXANDACurrent
63187-562CelecoxibCelecoxibProficient Rx LPANDACurrent
63187-562CelecoxibCelecoxibProficient Rx LPANDACurrent
67296-1608CelecoxibCelecoxibRedPharm Drug, Inc.ANDACurrent
67296-1608CelecoxibCelecoxibRedPharm Drug, Inc.ANDACurrent
67296-1608CelecoxibCelecoxibRedPharm Drug, Inc.ANDACurrent
68071-2164CelecoxibCelecoxibNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2169CelecoxibCelecoxibNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4252CelecoxibCelecoxibNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6941CelecoxibCelecoxibPreferred Pharmaceuticals Inc.ANDACurrent
68788-6941CelecoxibCelecoxibPreferred Pharmaceuticals Inc.ANDACurrent
68788-7134CelecoxibCelecoxibPreferred Pharmaceuticals IncANDACurrent
68788-7134CelecoxibCelecoxibPreferred Pharmaceuticals IncANDACurrent
68788-7134CelecoxibCelecoxibPreferred Pharmaceuticals IncANDACurrent
69677-154CelecoxibCelecoxibMas Management Group, Inc.ANDACurrent
70859-029NuDroxiPAKCelecoxib,Methyl Salicylate/Menthol/CapsaicinNuCare Pharmaceuticals,Inc.ANDACurrent
70859-029NuDroxiPAKCelecoxib,Methyl Salicylate/Menthol/CapsaicinNuCare Pharmaceuticals,Inc.ANDACurrent
70859-029NuDroxiPAKCelecoxib,Methyl Salicylate/Menthol/CapsaicinNuCare Pharmaceuticals,Inc.ANDACurrent
70934-026CelecoxibCelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-026CelecoxibCelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-026CelecoxibCelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-026CelecoxibCelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0292CelecoxibCelecoxibBryant Ranch PrepackANDACurrent
71335-0292CelecoxibCelecoxibBryant Ranch PrepackANDACurrent
71335-0292CelecoxibCelecoxibBryant Ranch PrepackANDACurrent
71335-0361CelecoxibCelecoxibBryant Ranch PrepackANDACurrent