Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085549
Company: WATSON LABS

Products on ANDA 085549

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE	25MG;15MG;0.1MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085549

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/1977	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
08/11/1993	SUPPL-46	Labeling		Label is not available on this site.
04/14/1992	SUPPL-45	Labeling		Label is not available on this site.
11/01/1991	SUPPL-44	Labeling		Label is not available on this site.
11/19/1990	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
07/03/1991	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.
06/29/1990	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
04/25/1989	SUPPL-40	Labeling		Label is not available on this site.
01/23/1989	SUPPL-39	Labeling		Label is not available on this site.
08/05/1988	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
08/05/1988	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
08/05/1988	SUPPL-36	Manufacturing (CMC)		Label is not available on this site.
11/30/1984	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
08/10/1984	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
04/22/1983	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
08/19/1982	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.