Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 083965
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 50MG 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
03/21/1977 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083965_hydrochlorothiazide_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/06/2000 SUPPL-96 Manufacturing (CMC)-Facility

Label is not available on this site.

03/13/1996 SUPPL-93 Labeling

Label is not available on this site.

08/02/1995 SUPPL-92 Labeling

Label is not available on this site.

03/13/1995 SUPPL-91 Labeling

Label is not available on this site.

07/15/1993 SUPPL-89 Labeling

Label is not available on this site.

11/13/1991 SUPPL-87 Labeling

Label is not available on this site.

07/25/1991 SUPPL-86 Labeling

Label is not available on this site.

08/03/1990 SUPPL-85 Labeling

Label is not available on this site.

08/03/1990 SUPPL-84 Labeling

Label is not available on this site.

08/03/1990 SUPPL-83 Labeling

Label is not available on this site.

02/12/1990 SUPPL-82 Labeling

Label is not available on this site.

04/04/1988 SUPPL-81 Labeling

Label is not available on this site.

01/18/1989 SUPPL-80 Manufacturing (CMC)

Label is not available on this site.

09/01/1988 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

08/09/1983 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

03/21/1983 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English