Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085549
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE 25MG;15MG;0.1MG 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
09/29/1977 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
08/11/1993 SUPPL-46 Labeling

Label is not available on this site.

04/14/1992 SUPPL-45 Labeling

Label is not available on this site.

11/01/1991 SUPPL-44 Labeling

Label is not available on this site.

11/19/1990 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

07/03/1991 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

04/25/1989 SUPPL-40 Labeling

Label is not available on this site.

01/23/1989 SUPPL-39 Labeling

Label is not available on this site.

08/05/1988 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

08/05/1988 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

08/05/1988 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

11/30/1984 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/10/1984 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/22/1983 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/19/1982 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

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