Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050199
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UNIPEN NAFCILLIN SODIUM EQ 250MG BASE/5ML FOR SOLUTION;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
10/11/1965 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
07/28/1982 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1980 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/03/1980 SUPPL-24 Labeling

Label is not available on this site.

10/02/1980 SUPPL-23 Labeling

Label is not available on this site.

05/15/1980 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1978 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1978 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1977 SUPPL-19 Labeling

Label is not available on this site.

10/15/1976 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/07/1976 SUPPL-17 Labeling

Label is not available on this site.

05/04/1976 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1976 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/26/1976 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/11/1974 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/24/1973 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1970 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1970 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/16/1967 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/05/1966 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1966 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1991 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/10/1991 SUPPL-5 Labeling

Label is not available on this site.

09/15/1987 SUPPL-4 Labeling

Label is not available on this site.

12/05/1986 SUPPL-3 Labeling

Label is not available on this site.

08/27/1985 SUPPL-2 Labeling

Label is not available on this site.

12/28/1982 SUPPL-1 Labeling

Label is not available on this site.

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