Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083711
Company: WATSON LABS

Products on ANDA 083711

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083711

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/1973	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
09/28/1989	SUPPL-63	Labeling		Label is not available on this site.
06/09/2005	SUPPL-44	Labeling		Label is not available on this site.
12/22/2004	SUPPL-42	Labeling		Label is not available on this site.
04/25/2001	SUPPL-38	Manufacturing (CMC)-Control		Label is not available on this site.
12/05/1997	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
12/16/1997	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
01/28/1991	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
06/29/1990	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
09/28/1989	SUPPL-31	Labeling		Label is not available on this site.
03/18/1988	SUPPL-27	Labeling		Label is not available on this site.
02/18/1986	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
02/18/1986	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
12/21/1983	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 083711

PROMETHAZINE HYDROCHLORIDE

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