Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088957
Company: STRIDES PHARMA INTL

Products on ANDA 088957

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDRA-ZIDE	HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	25MG;25MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088957

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/1985	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
11/29/1988	SUPPL-23	Labeling		Label is not available on this site.
08/20/2020	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
11/26/1997	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
11/26/1997	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
02/03/1995	SUPPL-16	Labeling		Label is not available on this site.
06/14/1991	SUPPL-15	Labeling		Label is not available on this site.
04/04/1991	SUPPL-14	Labeling		Label is not available on this site.
07/26/1989	SUPPL-13	Labeling		Label is not available on this site.
05/08/1989	SUPPL-12	Labeling		Label is not available on this site.
01/26/1989	SUPPL-11	Labeling		Label is not available on this site.
11/29/1988	SUPPL-10	Labeling		Label is not available on this site.
01/10/1989	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/10/1989	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/05/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.