FDA.report

Application 083312

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEINJECTABLE;INJECTION25MG/MLNoYes
002PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEINJECTABLE;INJECTION50MG/MLNoYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9940PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.ANDACurrent
0404-9940PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEHenry Schein, Inc.ANDACurrent
0404-9941Promethazine HydrochloridePromethazine HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9941Promethazine HydrochloridePromethazine HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9941Promethazine HydrochloridePromethazine HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9942Promethazine HydrochloridePromethazine HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9942Promethazine HydrochloridePromethazine HydrochlorideHenry Schein, Inc.ANDACurrent
0404-9942Promethazine HydrochloridePromethazine HydrochlorideHenry Schein, Inc.ANDACurrent
0641-0928Promethazine HydrochloridePromethazine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-0928Promethazine HydrochloridePromethazine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-0929Promethazine HydrochloridePromethazine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-0929Promethazine HydrochloridePromethazine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-0948Promethazine HydrochloridePromethazine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-0948Promethazine HydrochloridePromethazine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-0949Promethazine HydrochloridePromethazine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-0949Promethazine HydrochloridePromethazine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-0955Promethazine HydrochloridePromethazine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-0955Promethazine HydrochloridePromethazine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-0956Promethazine HydrochloridePromethazine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-0956Promethazine HydrochloridePromethazine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-1495Promethazine HydrochloridePromethazine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-1495Promethazine HydrochloridePromethazine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-1496Promethazine HydrochloridePromethazine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-1496Promethazine HydrochloridePromethazine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6082PHENERGANPromethazine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6082PHENERGANPromethazine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6083PHENERGANPromethazine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6083PHENERGANPromethazine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6084PHENERGANPromethazine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6084PHENERGANPromethazine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6085PHENERGANPromethazine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6085PHENERGANPromethazine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6099Promethazine HydrochloridePromethazine HydrochlorideWest-ward Pharmaceutical Corp.ANDACurrent
0641-6208Promethazine HydrochloridePromethazine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6208Promethazine HydrochloridePromethazine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
50090-0879Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-0879Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
51662-1247PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1247PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1247PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1247PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1247PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1248PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1248PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1248PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1248PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
51662-1248PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirstANDACurrent
52584-078PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-078PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-078PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEGeneral Injectables and Vaccines, Inc.ANDACurrent
52584-495Promethazine HydrochloridePromethazine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-495Promethazine HydrochloridePromethazine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-495Promethazine HydrochloridePromethazine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-495Promethazine HydrochloridePromethazine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-496Promethazine HydrochloridePromethazine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-496Promethazine HydrochloridePromethazine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-496Promethazine HydrochloridePromethazine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
52584-496Promethazine HydrochloridePromethazine HydrochlorideGeneral Injectables & Vaccines, IncANDACurrent
55154-2860Promethazine HydrochloridePromethazine HydrochlorideCardinal HealthANDACurrent
55154-2860Promethazine HydrochloridePromethazine HydrochlorideCardinal HealthANDACurrent
55154-2861Promethazine HydrochloridePromethazine HydrochlorideCardinal HealthANDACurrent
55154-2861Promethazine HydrochloridePromethazine HydrochlorideCardinal Health 107, LLCANDACurrent
55154-2861Promethazine HydrochloridePromethazine HydrochlorideCardinal HealthANDACurrent
68258-3028Promethazine HydrochloridePromethazine HydrochlorideDispensing Solutions Inc.ANDACurrent
70518-2656PHENERGANPromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2656PHENERGANPromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2896Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2896Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3340Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
71872-7077Promethazine HydrochloridePromethazine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent
71872-7077Promethazine HydrochloridePromethazine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent
71872-7285Promethazine HydrochloridePromethazine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent