U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087565
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 25MG 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
03/09/1982 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
08/20/2020 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

08/06/2020 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

12/01/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/12/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/27/1995 SUPPL-22 Labeling

Label is not available on this site.

01/24/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/30/1994 SUPPL-20 Labeling

Label is not available on this site.

08/11/1992 SUPPL-19 Labeling

Label is not available on this site.

10/31/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/07/1989 SUPPL-16 Labeling

Label is not available on this site.

09/02/1988 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/15/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/15/1986 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/15/1986 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/08/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/19/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/10/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/12/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Back to Top