Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050519
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEBCIN TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
06/11/1979 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
04/02/2003 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50477slr024,50519slr024ltr.pdf
12/07/2007 SUPPL-23 Labeling

Label is not available on this site.

10/01/1997 SUPPL-22 Efficacy-New Patient Population

Label is not available on this site.

01/02/1997 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/19/1997 SUPPL-19 Labeling

Label is not available on this site.

04/01/1993 SUPPL-18 Labeling

Label is not available on this site.

07/20/1982 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1982 SUPPL-16 Labeling

Label is not available on this site.

10/02/1981 SUPPL-15 Labeling

Label is not available on this site.

08/28/1981 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1981 SUPPL-13 Labeling

Label is not available on this site.

03/06/1981 SUPPL-12 Labeling

Label is not available on this site.

06/05/1981 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/30/1981 SUPPL-10 Labeling

Label is not available on this site.

09/18/1980 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1992 SUPPL-8 Labeling

Label is not available on this site.

10/28/1991 SUPPL-6 Labeling

Label is not available on this site.

11/04/1985 SUPPL-5 Labeling

Label is not available on this site.

05/20/1985 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/04/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/04/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/1983 SUPPL-1 Labeling

Label is not available on this site.

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