FDA.reportPublic FDA data

Application 091179

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL12.5MGNoNo
002PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL25MGNoNo
003PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-5195Promethazine HydrochloridePromethazine HydrochlorideLiberty Pharmaceuticals, Inc.ANDACurrent
10135-495Promethazine Hydrochloridepromethazine hydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-495Promethazine Hydrochloridepromethazine hydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-495Promethazine Hydrochloridepromethazine hydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-495Promethazine Hydrochloridepromethazine hydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-495Promethazine Hydrochloridepromethazine hydrochlorideMarlex Pharmaceuticals IncANDACurrent
12634-418Promethazine HydrochloridePromethazine HydrochlorideApotheca, IncANDACurrent
42254-045Promethazine HydrochloridePromethazine HydrochlorideRebel Distributors CorpANDACurrent
42708-119Promethazine HydrochloridePromethazine HydrochlorideQPharma IncANDACurrent
42708-119Promethazine HydrochloridePromethazine HydrochlorideQPharma IncANDACurrent
42708-119Promethazine HydrochloridePromethazine HydrochlorideQPharma IncANDACurrent
43063-405Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-405Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-405Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-405Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-447Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-447Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-447Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-447Promethazine HydrochloridePromethazine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3588Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3588Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50090-6216Promethazine HydrochloridePromethazine HydrochlorideA-S Medication SolutionsANDACurrent
50436-0521Promethazine HydrochloridePromethazine HydrochlorideUnit Dose ServicesANDACurrent
50436-0521Promethazine HydrochloridePromethazine HydrochlorideUnit Dose ServicesANDACurrent
51655-085Promethazine hydrochloridePromethazine hydrochlorideNorthwind PharmaceuticalsANDACurrent
53217-275Promethazine HydrochloridePromethazine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
53746-521Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-522Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
53746-745Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals of New York LLCANDACurrent
60760-830Promethazine HydrochloridePromethazine HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
61919-008PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDE tabletDirect RxANDACurrent
61919-047PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDirect_RxANDACurrent
61919-047PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDirect_RxANDACurrent
61919-047PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDirect RxANDACurrent
61919-047PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIERCT RXANDACurrent
61919-047PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDirect RxANDACurrent
61919-047PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIERCT RXANDACurrent
61919-047PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDirect_RxANDACurrent
61919-047PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDirect_RxANDACurrent
61919-047PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIERCT RXANDACurrent
61919-047PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDirect RxANDACurrent
61919-228PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-228PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-228PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEDIRECT RXANDACurrent
63187-949Promethazine HydrochloridePromethazine HydrochlorideProficient Rx LPANDACurrent
63629-6875Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
63629-6875Promethazine HydrochloridePromethazine HydrochlorideBryant Ranch PrepackANDACurrent
64205-521Promethazine HydrochloridePromethazine HydrochlorideReadyMedsANDACurrent
64205-745Promethazine HydrochloridePromethazine HydrochlorideReadyMedsANDACurrent
65162-521Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-521Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-521Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-521Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-522Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-522Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-522Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-522Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-745Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-745Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-745Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-745Promethazine HydrochloridePromethazine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
67046-374Promethazine HydrochloridePromethazine HydrochlorideContract Pharmacy Services-PAANDACurrent
67296-1120Promethazine HydrochloridePromethazine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1120Promethazine HydrochloridePromethazine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1120Promethazine HydrochloridePromethazine HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-3095Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3129Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3233Promethazine HydrochloridePromethazine HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-9270Promethazine HydrochloridePromethazine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9270Promethazine HydrochloridePromethazine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0141Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0141Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0141Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0141Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0165Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0165Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0165Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0165Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0165Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0165Promethazine HydrochloridePromethazine HydrochlorideREMEDYREPACK INC.ANDACurrent