Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011949
Company: SHIRE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SALURON HYDROFLUMETHIAZIDE 50MG TABLET;ORAL Discontinued None Yes 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
07/22/1959 ORIG-1 Approval Type 1 - New Molecular Entity 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-25 Manufacturing (CMC)

Label is not available on this site.

12/02/1988 SUPPL-24 Labeling

Label is not available on this site.

07/28/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/27/1985 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1984 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/09/1984 SUPPL-20 Labeling

Label is not available on this site.

11/07/1983 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/27/1985 SUPPL-18 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/07/1983 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/07/1983 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1985 SUPPL-15 Labeling

Label is not available on this site.

05/06/1980 SUPPL-14 Labeling

Label is not available on this site.

11/14/1986 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/13/1979 SUPPL-12 Labeling

Label is not available on this site.

01/30/1981 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1978 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1977 SUPPL-9 Labeling

Label is not available on this site.

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