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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064065
Company: BAUSCH AND LOMB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OTICAIR 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
08/28/1996 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
04/18/2003 SUPPL-24 Labeling

Label is not available on this site.
04/17/2002 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
06/12/2002 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
02/05/2002 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.
11/27/2001 SUPPL-19 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
03/07/2001 SUPPL-18 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
02/02/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
09/15/2000 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
06/27/2000 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
08/21/2000 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
04/28/2000 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
06/07/1999 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
03/05/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
04/28/2000 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
11/19/1998 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
06/15/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
05/04/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
05/19/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
11/12/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
09/18/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
09/03/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
04/29/1997 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

OTICAIR

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
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
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