Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050320
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UNIPEN NAFCILLIN SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
UNIPEN NAFCILLIN SODIUM EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
UNIPEN NAFCILLIN SODIUM EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
UNIPEN NAFCILLIN SODIUM EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
UNIPEN NAFCILLIN SODIUM EQ 20GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
UNIPEN IN PLASTIC CONTAINER NAFCILLIN SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
06/23/1970 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
08/12/1982 SUPPL-70 Labeling

Label is not available on this site.

05/12/1982 SUPPL-69 Labeling

Label is not available on this site.

06/01/1981 SUPPL-68 Labeling

Label is not available on this site.

06/01/1981 SUPPL-67 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1981 SUPPL-66 Labeling

Label is not available on this site.

04/08/1981 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

11/21/1980 SUPPL-64 Labeling

Label is not available on this site.

08/20/1980 SUPPL-63 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/30/1979 SUPPL-62 Labeling

Label is not available on this site.

02/23/1979 SUPPL-61 Labeling

Label is not available on this site.

02/23/1979 SUPPL-60 Labeling

Label is not available on this site.

12/21/1978 SUPPL-59 Labeling

Label is not available on this site.

12/21/1978 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1978 SUPPL-57 Labeling

Label is not available on this site.

02/06/1978 SUPPL-56 Labeling

Label is not available on this site.

12/22/1977 SUPPL-55 Labeling

Label is not available on this site.

10/04/1977 SUPPL-54 Labeling

Label is not available on this site.

01/19/1978 SUPPL-53 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/19/1978 SUPPL-52 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

08/10/1977 SUPPL-51 Labeling

Label is not available on this site.

06/01/1977 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1977 SUPPL-49 Labeling

Label is not available on this site.

06/20/1977 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1977 SUPPL-46 Labeling

Label is not available on this site.

01/11/1977 SUPPL-45 Labeling

Label is not available on this site.

09/23/1976 SUPPL-44 Labeling

Label is not available on this site.

09/07/1976 SUPPL-43 Labeling

Label is not available on this site.

09/07/1976 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1976 SUPPL-41 Labeling

Label is not available on this site.

03/23/1976 SUPPL-40 Labeling

Label is not available on this site.

03/23/1976 SUPPL-39 Labeling

Label is not available on this site.

02/13/1976 SUPPL-38 Labeling

Label is not available on this site.

05/22/1975 SUPPL-36 Labeling

Label is not available on this site.

08/19/1975 SUPPL-35 Labeling

Label is not available on this site.

01/23/1975 SUPPL-34 Labeling

Label is not available on this site.

08/02/1974 SUPPL-31 Labeling

Label is not available on this site.

03/12/1974 SUPPL-30 Labeling

Label is not available on this site.

01/24/1974 SUPPL-29 Labeling

Label is not available on this site.

11/23/1973 SUPPL-28 Labeling

Label is not available on this site.

11/19/1973 SUPPL-27 Labeling

Label is not available on this site.

01/11/1972 SUPPL-24 Labeling

Label is not available on this site.

12/06/1971 SUPPL-23 Labeling

Label is not available on this site.

10/22/1971 SUPPL-22 Labeling

Label is not available on this site.

09/24/1971 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1972 SUPPL-20 Labeling

Label is not available on this site.

05/19/1971 SUPPL-19 Labeling

Label is not available on this site.

05/18/1971 SUPPL-18 Labeling

Label is not available on this site.

04/02/1971 SUPPL-17 Labeling

Label is not available on this site.

12/11/1970 SUPPL-16 Labeling

Label is not available on this site.

08/10/1970 SUPPL-15 Labeling

Label is not available on this site.

08/31/1988 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/1988 SUPPL-11 Labeling

Label is not available on this site.

12/19/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1988 SUPPL-9 Labeling

Label is not available on this site.

07/08/1987 SUPPL-8 Labeling

Label is not available on this site.

04/14/1987 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1985 SUPPL-6 Labeling

Label is not available on this site.

07/29/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/03/1985 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/19/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/1982 SUPPL-1 Labeling

Label is not available on this site.

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