Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012359
Company: SHIRE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SALUTENSIN HYDROFLUMETHIAZIDE; RESERPINE 50MG;0.125MG TABLET;ORAL Discontinued None No No
SALUTENSIN-DEMI HYDROFLUMETHIAZIDE; 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
06/20/1960 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/24/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

10/07/1992 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

07/09/1990 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/22/1988 SUPPL-29 Labeling

Label is not available on this site.

10/24/1986 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

06/27/1986 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/01/1985 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1985 SUPPL-25 Labeling

Label is not available on this site.

06/08/1984 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/23/1983 SUPPL-23 Labeling

Label is not available on this site.

05/10/1984 SUPPL-22 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/03/1982 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1982 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/03/1981 SUPPL-19 Labeling

Label is not available on this site.

07/29/1985 SUPPL-18 Labeling

Label is not available on this site.

06/10/1982 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/31/1979 SUPPL-16 Labeling

Label is not available on this site.

10/03/1980 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/1980 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1978 SUPPL-13 Labeling

Label is not available on this site.

05/15/1978 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/27/1978 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1978 SUPPL-9 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/23/1977 SUPPL-6 Labeling

Label is not available on this site.

12/13/1977 SUPPL-5 Unspecified

Label is not available on this site.

06/23/1977 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

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