Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062423
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 SOLUTION/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
08/25/1983 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
12/24/2002 SUPPL-28 Labeling

Label is not available on this site.

12/23/2002 SUPPL-27 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/24/2002 SUPPL-26 Manufacturing (CMC)-Facility

Label is not available on this site.

12/24/2002 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

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

Label is not available on this site.

12/24/2002 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/19/1999 SUPPL-20 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

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

Label is not available on this site.

04/16/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/14/1994 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/27/1993 SUPPL-16 Labeling

Label is not available on this site.

12/03/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/23/1991 SUPPL-14 Labeling

Label is not available on this site.

01/27/1989 SUPPL-13 Labeling

Label is not available on this site.

11/08/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

SOLUTION/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
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS;OTIC Prescription No AT 064053 BAUSCH AND LOMB
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS;OTIC Prescription No AT 062423 SANDOZ INC

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