Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062874
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS;OPHTHALMIC Prescription None 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
05/11/1988 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
05/25/2006 SUPPL-21 Labeling

Label is not available on this site.

10/21/2004 SUPPL-19 Labeling

Label is not available on this site.

02/04/2003 SUPPL-11 Labeling

Label is not available on this site.

02/19/1999 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/15/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/16/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/16/1994 SUPPL-5 Labeling

Label is not available on this site.

12/21/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/06/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/31/1989 SUPPL-2 Manufacturing (CMC)

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