Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088761
Company: G AND W LABS INC

Products on ANDA 088761

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088761

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/08/1984	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
08/01/2011	SUPPL-78	Labeling		Label is not available on this site.
10/06/2005	SUPPL-64	Labeling		Label is not available on this site.
05/02/2005	SUPPL-55	Labeling		Label is not available on this site.
06/06/2003	SUPPL-49	Labeling		Label is not available on this site.
10/03/2001	SUPPL-48	Manufacturing (CMC)-Control		Label is not available on this site.
10/03/2001	SUPPL-47	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/02/2000	SUPPL-46	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/01/1998	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
09/02/1997	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
11/08/1996	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
06/18/1996	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
05/07/1996	SUPPL-35	Labeling		Label is not available on this site.
05/07/1996	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
05/07/1996	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
10/23/1995	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
05/07/1996	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
05/07/1996	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
05/30/1996	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
05/30/1996	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
02/02/1994	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
09/27/1991	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
04/23/1991	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
09/28/1990	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
01/23/1991	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
12/06/1990	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
06/01/1990	SUPPL-21	Labeling		Label is not available on this site.
12/22/1989	SUPPL-20	Labeling		Label is not available on this site.
05/25/1990	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
05/25/1990	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/25/1990	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/15/1988	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
12/15/1988	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/17/1987	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/18/1986	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/18/1986	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/18/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/13/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/13/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/14/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.