Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017603
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOVAFED PSEUDOEPHEDRINE HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;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
08/29/1975 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
06/21/1996 SUPPL-33 Labeling

Label is not available on this site.

06/24/1992 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1992 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1984 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/09/1983 SUPPL-25 Labeling

Label is not available on this site.

02/02/1982 SUPPL-24 Labeling

Label is not available on this site.

10/23/1981 SUPPL-23 Labeling

Label is not available on this site.

10/09/1981 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1981 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1981 SUPPL-19 Labeling

Label is not available on this site.

09/15/1980 SUPPL-18 Labeling

Label is not available on this site.

11/09/1979 SUPPL-17 Labeling

Label is not available on this site.

07/03/1980 SUPPL-16 Labeling

Label is not available on this site.

07/03/1980 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/06/1978 SUPPL-14 Labeling

Label is not available on this site.

05/02/1978 SUPPL-13 Labeling

Label is not available on this site.

08/11/1978 SUPPL-12 Labeling

Label is not available on this site.

02/11/1977 SUPPL-10 Labeling

Label is not available on this site.

01/18/1977 SUPPL-9 Labeling

Label is not available on this site.

09/17/1976 SUPPL-8 Labeling

Label is not available on this site.

09/07/1976 SUPPL-7 Labeling

Label is not available on this site.

01/18/1977 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/17/1976 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1976 SUPPL-4 Labeling

Label is not available on this site.

02/27/1976 SUPPL-3 Labeling

Label is not available on this site.

01/27/1976 SUPPL-2 Labeling

Label is not available on this site.

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