Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050544
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NETROMYCIN NETILMICIN SULFATE EQ 10MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
NETROMYCIN NETILMICIN SULFATE EQ 25MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
NETROMYCIN NETILMICIN SULFATE EQ 100MG BASE/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
02/28/1983 ORIG-1 Approval Type 1 - New Molecular Entity 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
01/13/1998 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/1997 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/01/1997 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/22/1994 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/14/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/15/1987 SUPPL-10 Labeling

Label is not available on this site.

03/12/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1984 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/1984 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/18/1984 SUPPL-4 Labeling

Label is not available on this site.

03/28/1983 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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