Drugs@FDA: FDA-Approved Drugs

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

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