Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
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. |
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12/23/2002 | SUPPL-20 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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12/24/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/24/2002 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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12/24/2002 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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12/24/2002 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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12/24/2002 | SUPPL-14 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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02/19/1999 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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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. |
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05/25/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
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03/14/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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11/18/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
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02/28/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
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01/10/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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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 |
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 |