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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080629
Company: WATSON LABS

Products on ANDA 080629

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	50MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080629

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/29/1974	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
09/27/2004	SUPPL-218	Labeling		Label is not available on this site.
06/09/2003	SUPPL-215	Labeling		Label is not available on this site.
11/20/2002	SUPPL-210	Manufacturing (CMC)-Formulation		Label is not available on this site.
02/19/1999	SUPPL-208	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-207	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/04/1996	SUPPL-206	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/06/1992	SUPPL-205	Manufacturing (CMC)		Label is not available on this site.
01/11/1991	SUPPL-204	Labeling		Label is not available on this site.
04/09/1990	SUPPL-203	Labeling		Label is not available on this site.
10/12/1989	SUPPL-202	Labeling		Label is not available on this site.
10/12/1989	SUPPL-201	Labeling		Label is not available on this site.
04/11/1989	SUPPL-200	Manufacturing (CMC)		Label is not available on this site.
04/11/1989	SUPPL-199	Manufacturing (CMC)		Label is not available on this site.
08/03/1988	SUPPL-196	Manufacturing (CMC)		Label is not available on this site.
08/03/1988	SUPPL-195	Manufacturing (CMC)		Label is not available on this site.
06/16/1986	SUPPL-191	Manufacturing (CMC)		Label is not available on this site.
11/03/1982	SUPPL-187	Manufacturing (CMC)		Label is not available on this site.
04/23/1982	SUPPL-184	Manufacturing (CMC)		Label is not available on this site.
04/23/1982	SUPPL-155	Manufacturing (CMC)		Label is not available on this site.

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