Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085683
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
08/17/1977 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
10/06/2000 SUPPL-57 Manufacturing (CMC)-Facility

Label is not available on this site.

03/13/1996 SUPPL-54 Labeling

Label is not available on this site.

08/02/1995 SUPPL-53 Labeling

Label is not available on this site.

03/13/1995 SUPPL-52 Labeling

Label is not available on this site.

07/15/1993 SUPPL-50 Labeling

Label is not available on this site.

11/13/1991 SUPPL-48 Labeling

Label is not available on this site.

07/25/1991 SUPPL-47 Labeling

Label is not available on this site.

12/04/1990 SUPPL-46 Labeling

Label is not available on this site.

08/03/1990 SUPPL-45 Labeling

Label is not available on this site.

01/31/1990 SUPPL-44 Labeling

Label is not available on this site.

03/24/1989 SUPPL-43 Labeling

Label is not available on this site.

05/02/1989 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

01/23/1989 SUPPL-41 Labeling

Label is not available on this site.

03/24/1988 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

06/06/1983 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

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