Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017769
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCIMAR CALCITONIN SALMON 200 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
04/17/1978 ORIG-1 Approval Type 3 - New Dosage Form 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
05/16/1996 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

07/06/1993 SUPPL-25 Labeling

Label is not available on this site.

09/24/1993 SUPPL-24 Labeling

Label is not available on this site.

07/12/1993 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1992 SUPPL-22 Labeling

Label is not available on this site.

06/01/1992 SUPPL-21 Labeling

Label is not available on this site.

04/08/1991 SUPPL-20 Labeling

Label is not available on this site.

04/04/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/21/1990 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/06/1989 SUPPL-17 Labeling

Label is not available on this site.

03/22/1988 SUPPL-16 Labeling

Label is not available on this site.

08/08/1986 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/10/1984 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-12 Labeling

Label is not available on this site.

12/07/2007 SUPPL-10 Labeling

Label is not available on this site.

12/07/2007 SUPPL-8 Labeling

Label is not available on this site.

05/04/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1979 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1979 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1979 SUPPL-2 Labeling

Label is not available on this site.

08/14/1978 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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