Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018621
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NITRO-BID NITROGLYCERIN 5MG/ML INJECTABLE;INJECTION 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
01/05/1982 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
09/29/1997 SUPPL-21 Labeling

Label is not available on this site.

12/15/1997 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/29/1996 SUPPL-19 Labeling

Label is not available on this site.

07/11/1996 SUPPL-18 Labeling

Label is not available on this site.

06/22/1995 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/30/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/21/1993 SUPPL-14 Labeling

Label is not available on this site.

11/18/1992 SUPPL-13 Labeling

Label is not available on this site.

09/21/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/21/1989 SUPPL-10 Labeling

Label is not available on this site.

09/21/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/21/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/16/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/14/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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