Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088570
Company: SUN PHARM INDUSTRIES

Products on ANDA 088570

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 088570

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/10/1984	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
08/28/2020	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
12/01/1998	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
03/13/1992	SUPPL-17	Labeling		Label is not available on this site.
04/03/1992	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
11/21/1991	SUPPL-15	Labeling		Label is not available on this site.
06/16/1989	SUPPL-13	Labeling		Label is not available on this site.
12/08/1987	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
04/01/1987	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/22/1986	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/22/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/09/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.