Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 060304
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOMYCIN SULFATE NEOMYCIN SULFATE 500MG TABLET;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/02/1964 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
02/08/2012 SUPPL-47 Labeling-Package Insert

Label is not available on this site.

12/03/2007 SUPPL-42 Labeling

Label is not available on this site.

11/04/2003 SUPPL-34 Labeling

Label is not available on this site.

02/27/2002 SUPPL-32 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

09/25/2000 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

07/07/2000 SUPPL-30 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-29 Manufacturing (CMC)-Facility

Label is not available on this site.

06/18/1997 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/26/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/26/1995 SUPPL-26 Labeling

Label is not available on this site.

02/16/1995 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/06/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/11/1995 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/09/1993 SUPPL-22 Labeling

Label is not available on this site.

10/30/1992 SUPPL-21 Labeling

Label is not available on this site.

NEOMYCIN SULFATE

TABLET;ORAL; 500MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NEOMYCIN SULFATE NEOMYCIN SULFATE 500MG TABLET;ORAL Prescription No AA 065468 BRECKENRIDGE
NEOMYCIN SULFATE NEOMYCIN SULFATE 500MG TABLET;ORAL Prescription No AA 060304 TEVA
NEOMYCIN SULFATE NEOMYCIN SULFATE 500MG TABLET;ORAL Prescription No AA 065220 X GEN PHARMS

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