FDA.reportPublic FDA data

Application 204590

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

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
33342-155celecoxibcelecoxibMacleods Pharmaceuticals LimitedANDACurrent
33342-155celecoxibcelecoxibMacleods Pharmaceuticals LimitedANDACurrent
33342-156celecoxibcelecoxibMacleods Pharmaceuticals LimitedANDACurrent
33342-156celecoxibcelecoxibMacleods Pharmaceuticals LimitedANDACurrent
33342-157celecoxibcelecoxibMacleods Pharmaceuticals LimitedANDACurrent
33342-157celecoxibcelecoxibMacleods Pharmaceuticals LimitedANDACurrent
33342-158celecoxibcelecoxibMacleods Pharmaceuticals LimitedANDACurrent
33342-158celecoxibcelecoxibMacleods Pharmaceuticals LimitedANDACurrent
43063-967celecoxibcelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-967celecoxibcelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-967celecoxibcelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-967celecoxibcelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-967celecoxibcelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-967celecoxibcelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-967celecoxibcelecoxibPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-967celecoxibcelecoxibPD-Rx Pharmaceuticals, InANDACurrent
51655-253celecoxibcelecoxibNorthwind PharmaceuticalsANDACurrent
55700-607celecoxibcelecoxibLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-607celecoxibcelecoxibLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-607celecoxibcelecoxibLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-607celecoxibcelecoxibLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-613celecoxibcelecoxibLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-613celecoxibcelecoxibLake Erie Medical DBA QuaANDACurrent
55700-613celecoxibcelecoxibLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-613celecoxibcelecoxibLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-823celecoxibcelecoxibSt. Mary's Medical Park PharmacyANDACurrent
60760-823celecoxibcelecoxibSt. Mary's Medical Park PharmacyANDACurrent
60760-824celecoxibcelecoxibSt. Mary's Medical Park PharmacyANDACurrent
61919-682CELECOXIBCELECOXIBDIRECT RXANDACurrent
61919-682CELECOXIBCELECOXIBDirect_RxANDACurrent
61919-682CELECOXIBCELECOXIBDirect_RxANDACurrent
61919-682CELECOXIBCELECOXIBDirect_RxANDACurrent
61919-837CelecoxibCelecoxibDirect_RxANDACurrent
61919-837CelecoxibCelecoxibDirect_RxANDACurrent
61919-837CelecoxibCelecoxibDirect_RxANDACurrent
61919-837CelecoxibCelecoxibDirect_RxANDACurrent
61919-837CelecoxibCelecoxibDirect_RxANDACurrent
61919-837CELECOXIBCELECOXIBDIRECT RXANDACurrent
67296-1399celecoxibcelecoxibRedPharm Drug, Inc.ANDACurrent
67296-1399celecoxibcelecoxibRedPharm Drug, Inc.ANDACurrent
67296-1399celecoxibcelecoxibRedPharm Drug, Inc.ANDACurrent
68071-4392celecoxibcelecoxibNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4392celecoxibcelecoxibNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7264celecoxibcelecoxibPreferred Pharmaceuticals Inc.ANDACurrent
68788-7264celecoxibcelecoxibPreferred Pharmaceuticals Inc.ANDACurrent
68788-7264celecoxibcelecoxibPreferred Pharmaceuticals Inc.ANDACurrent
68788-7286celecoxibcelecoxibPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7286celecoxibcelecoxibPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7286celecoxibcelecoxibPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7286celecoxibcelecoxibPreferred Pharmaceuticals, Inc.ANDACurrent
70518-1346celecoxibcelecoxibREMEDYREPACK INC.ANDACurrent
70518-1346celecoxibcelecoxibREMEDYREPACK INC.ANDACurrent
70518-1346celecoxibcelecoxibREMEDYREPACK INC.ANDACurrent
70518-1346celecoxibcelecoxibREMEDYREPACK INC.ANDACurrent
70518-1346celecoxibcelecoxibREMEDYREPACK INC.ANDACurrent
70518-1346celecoxibcelecoxibREMEDYREPACK INC.ANDACurrent
70518-1346celecoxibcelecoxibREMEDYREPACK INC.ANDACurrent
70518-1346celecoxibcelecoxibREMEDYREPACK INC.ANDACurrent
70518-1650celecoxibcelecoxibREMEDYREPACK INC.ANDACurrent
70518-1650celecoxibcelecoxibREMEDYREPACK INC.ANDACurrent
70518-2922celecoxibcelecoxibREMEDYREPACK INC.ANDACurrent
70518-2922celecoxibcelecoxibREMEDYREPACK INC.ANDACurrent
70934-220celecoxibcelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-220celecoxibcelecoxibDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-027celecoxibcelecoxibProficient Rx LPANDACurrent
71205-027celecoxibcelecoxibProficient Rx LPANDACurrent
71205-027celecoxibcelecoxibProficient Rx LPANDACurrent
71205-027celecoxibcelecoxibProficient Rx LPANDACurrent
71205-027celecoxibcelecoxibProficient Rx LPANDACurrent
71205-027celecoxibcelecoxibProficient Rx LPANDACurrent
71205-439celecoxibcelecoxibProficient Rx LPANDACurrent
71205-439celecoxibcelecoxibProficient Rx LPANDACurrent
71335-0868celecoxibcelecoxibBryant Ranch PrepackANDACurrent
71335-0868celecoxibcelecoxibBryant Ranch PrepackANDACurrent
71335-0936celecoxibcelecoxibBryant Ranch PrepackANDACurrent
71335-0936celecoxibcelecoxibBryant Ranch PrepackANDACurrent
72189-123CELECOXIBCELECOXIBDirect RxANDACurrent
72189-123CELECOXIBCELECOXIBDirect RxANDACurrent
72189-123CELECOXIBCELECOXIBDirect RxANDACurrent
76420-009celecoxibcelecoxibAsclemed USA, Inc.ANDACurrent