Drugs@FDA: FDA-Approved Drugs
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. |
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04/17/2002 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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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. |
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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 |