Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 050477
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEBCIN TOBRAMYCIN SULFATE EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
06/11/1975 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
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
03/04/1999 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-22 Labeling

Label is not available on this site.

10/01/1997 SUPPL-21 Efficacy-New Patient Population

Label is not available on this site.

04/03/1997 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/19/1997 SUPPL-18 Labeling

Label is not available on this site.

05/13/1997 SUPPL-17 Labeling

Label is not available on this site.

04/01/1993 SUPPL-16 Labeling

Label is not available on this site.

08/06/1992 SUPPL-15 Labeling

Label is not available on this site.

05/28/1980 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/02/1976 SUPPL-13 Labeling

Label is not available on this site.

02/23/1976 SUPPL-12 Labeling

Label is not available on this site.

01/13/1976 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/03/1975 SUPPL-10 Efficacy-New Dosing Regimen

Label is not available on this site.

07/30/1975 SUPPL-9 Labeling

Label is not available on this site.

10/28/1991 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/28/1991 SUPPL-7 Labeling

Label is not available on this site.

07/21/1987 SUPPL-6 Labeling

Label is not available on this site.

04/02/1987 SUPPL-5 Labeling

Label is not available on this site.

03/05/1987 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

11/04/1985 SUPPL-3 Labeling

Label is not available on this site.

09/28/1984 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/1984 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English