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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040596
Company: ZYDUS PHARMS USA

Products on ANDA 040596

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040596

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.

Therapeutic Equivalents for ANDA 040596

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	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	Yes	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	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	Yes	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	083711	WATSON LABS
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	040596	ZYDUS PHARMS USA

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