Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083972
Company: SUN PHARM INDUSTRIES

Products on ANDA 083972

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Discontinued	None	No	No
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Discontinued	None	No	No
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083972

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/03/1974	ORIG-1	Approval			Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083972_hydrochlorothiazide_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2020	SUPPL-175	Labeling-Package Insert		Label is not available on this site.
12/01/1998	SUPPL-174	Manufacturing (CMC)		Label is not available on this site.
12/23/1994	SUPPL-173	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-172	Manufacturing (CMC)		Label is not available on this site.
05/24/1994	SUPPL-171	Labeling		Label is not available on this site.
02/12/1993	SUPPL-170	Labeling		Label is not available on this site.
08/18/1992	SUPPL-169	Labeling		Label is not available on this site.
04/03/1992	SUPPL-168	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-166	Manufacturing (CMC)		Label is not available on this site.
08/06/1990	SUPPL-164	Labeling		Label is not available on this site.
04/02/1991	SUPPL-163	Manufacturing (CMC)		Label is not available on this site.
04/02/1991	SUPPL-162	Manufacturing (CMC)		Label is not available on this site.
12/28/1989	SUPPL-161	Labeling		Label is not available on this site.
02/05/1986	SUPPL-153	Manufacturing (CMC)		Label is not available on this site.
02/05/1986	SUPPL-152	Manufacturing (CMC)		Label is not available on this site.
03/29/1985	SUPPL-151	Manufacturing (CMC)		Label is not available on this site.
03/29/1985	SUPPL-150	Manufacturing (CMC)		Label is not available on this site.
12/18/1984	SUPPL-149	Manufacturing (CMC)		Label is not available on this site.
12/18/1984	SUPPL-148	Manufacturing (CMC)		Label is not available on this site.
05/25/1982	SUPPL-142	Manufacturing (CMC)		Label is not available on this site.
05/25/1982	SUPPL-140	Manufacturing (CMC)		Label is not available on this site.
05/25/1982	SUPPL-109	Manufacturing (CMC)		Label is not available on this site.