Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040596
Company: ZYDUS PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription AB No No
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AB No No
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/18/2005 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/17/2007 SUPPL-4 Labeling

Label is not available on this site.

PROMETHAZINE HYDROCHLORIDE

TABLET;ORAL; 12.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AB 091179 AMNEAL PHARMS NY
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AB 040712 KVK TECH
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AB 040622 PRINSTON INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AB 040673 QUAGEN
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AB 209177 STRIDES PHARMA
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AB 040863 SUN PHARM INDS INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 12.5MG TABLET;ORAL Prescription No AB 040596 ZYDUS PHARMS USA

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 091179 AMNEAL PHARMS NY
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040712 KVK TECH
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040622 PRINSTON INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040673 QUAGEN
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 084176 SANDOZ
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 209177 STRIDES PHARMA
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040863 SUN PHARM INDS INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 083426 WATSON LABS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 040596 ZYDUS PHARMS USA

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 091179 AMNEAL PHARMS NY
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040712 KVK TECH
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040713 KVK TECH
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040622 PRINSTON INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040673 QUAGEN
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 084176 SANDOZ
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 209177 STRIDES PHARMA
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040863 SUN PHARM INDS INC
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 083711 WATSON LABS
PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 040596 ZYDUS PHARMS USA

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