Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084466
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCHLOROTHIAZIDE W/ RESERPINE HYDROCHLOROTHIAZIDE; RESERPINE 25MG;0.125MG 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
01/07/1977 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
09/27/1994 SUPPL-28 Labeling

Label is not available on this site.

07/25/1991 SUPPL-27 Labeling

Label is not available on this site.

11/19/1990 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/19/1989 SUPPL-23 Labeling

Label is not available on this site.

06/17/1988 SUPPL-22 Labeling

Label is not available on this site.

07/18/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/18/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/18/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/25/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/01/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/29/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/30/1981 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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