Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084591
Company: WATSON LABS

Products on ANDA 084591

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE	25MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084591

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/15/1978	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
04/09/1999	SUPPL-85	Manufacturing (CMC)		Label is not available on this site.
02/19/1999	SUPPL-83	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-82	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/04/1996	SUPPL-81	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/03/1993	SUPPL-80	Manufacturing (CMC)		Label is not available on this site.
09/28/1990	SUPPL-79	Labeling		Label is not available on this site.
02/25/1993	SUPPL-78	Manufacturing (CMC)		Label is not available on this site.
03/28/1990	SUPPL-77	Labeling		Label is not available on this site.
09/22/1989	SUPPL-76	Labeling		Label is not available on this site.
11/18/1988	SUPPL-73	Manufacturing (CMC)		Label is not available on this site.
11/18/1988	SUPPL-72	Manufacturing (CMC)		Label is not available on this site.
07/17/1986	SUPPL-68	Manufacturing (CMC)		Label is not available on this site.
01/12/1983	SUPPL-66	Manufacturing (CMC)		Label is not available on this site.
06/14/1982	SUPPL-65	Manufacturing (CMC)		Label is not available on this site.