Drugs@FDA: FDA-Approved Drugs
Company: BAUSCH AND LOMB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXASPORIN | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OPHTHALMIC | 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 |
---|---|---|---|---|---|---|---|
09/13/1995 | 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 |
---|---|---|---|---|---|
07/21/2023 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
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02/07/2020 | SUPPL-34 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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02/05/2002 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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11/27/2001 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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03/07/2001 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/27/2000 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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08/21/2000 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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05/02/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/28/2000 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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07/02/1999 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
11/19/1998 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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04/10/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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02/11/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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08/19/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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01/14/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DEXASPORIN
SUSPENSION/DROPS;OPHTHALMIC; 0.1%;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 |
---|---|---|---|---|---|---|---|---|
DEXASPORIN | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AT | 064135 | BAUSCH AND LOMB |
MAXITROL | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 050023 | HARROW EYE |
MAXITROL | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AT | 062341 | SANDOZ |