Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062488
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;OTIC Prescription AT 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
11/06/1985 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/62488_Neomycin.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/24/2002 SUPPL-21 Labeling

Label is not available on this site.

12/23/2002 SUPPL-20 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/24/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/24/2002 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/24/2002 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/24/2002 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

12/24/2002 SUPPL-14 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/19/1999 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/02/1999 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/16/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/25/1994 SUPPL-8 Labeling

Label is not available on this site.

03/14/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/18/1992 SUPPL-6 Labeling

Label is not available on this site.

02/28/1991 SUPPL-5 Labeling

Label is not available on this site.

01/10/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/27/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

SUSPENSION/DROPS;OTIC; 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CASPORYN HC HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS;OTIC Prescription Yes AT 060613 CASPER PHARMA LLC
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;OTIC Prescription No AT 065219 AMRING PHARMS
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;OTIC Prescription No AT 062488 SANDOZ INC
OTICAIR HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS;OTIC Prescription No AT 064065 BAUSCH AND LOMB

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