Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085953
Company: ACTAVIS MID ATLANTIC

Products on ANDA 085953

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETH PLAIN	PROMETHAZINE HYDROCHLORIDE	6.25MG/5ML	SYRUP;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085953

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/21/1978	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
10/03/2001	SUPPL-51	Manufacturing (CMC)-Control		Label is not available on this site.
10/03/2001	SUPPL-50	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/13/2001	SUPPL-49	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/20/2000	SUPPL-48	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/17/1999	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
06/17/1999	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
08/04/1997	SUPPL-40	Manufacturing (CMC)		Label is not available on this site.
01/16/1997	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
07/05/1996	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
08/08/1996	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
08/08/1996	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
08/08/1996	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
08/08/1996	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
10/30/1997	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
10/30/1997	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
06/04/1993	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
09/28/1990	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
12/27/1990	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
05/01/1990	SUPPL-22	Labeling		Label is not available on this site.
05/01/1990	SUPPL-21	Labeling		Label is not available on this site.
11/21/1989	SUPPL-20	Labeling		Label is not available on this site.
05/16/1990	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
02/08/1989	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
02/08/1989	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
02/12/1986	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/05/1985	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/25/1983	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.