Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050285
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCIFRADIN NEOMYCIN SULFATE EQ 87.5MG BASE/5ML 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
03/13/2009 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/1994 SUPPL-34 Labeling

Label is not available on this site.

02/22/1994 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1992 SUPPL-31 Labeling

Label is not available on this site.

08/23/1984 SUPPL-30 Labeling

Label is not available on this site.

08/23/1984 SUPPL-29 Labeling

Label is not available on this site.

02/05/1982 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1981 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1979 SUPPL-26 Labeling

Label is not available on this site.

02/27/1979 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/1978 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/26/1978 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1976 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

12/08/1975 SUPPL-21 Labeling

Label is not available on this site.

07/01/1975 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

01/23/1975 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/20/1975 SUPPL-18 Labeling

Label is not available on this site.

11/11/1974 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1974 SUPPL-16 Labeling

Label is not available on this site.

05/01/1974 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1974 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/26/1973 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/19/1972 SUPPL-12 Labeling

Label is not available on this site.

03/13/2009 SUPPL-11 Labeling

Label is not available on this site.

04/26/1972 SUPPL-10 Labeling

Label is not available on this site.

04/19/1972 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/1972 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/01/1971 SUPPL-7 Labeling

Label is not available on this site.

04/26/1971 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/18/1971 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1971 SUPPL-4 Labeling

Label is not available on this site.

02/23/1971 SUPPL-3 Labeling

Label is not available on this site.

07/11/1988 SUPPL-2 Labeling

Label is not available on this site.

01/20/1983 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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