Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MAXITROL | 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 |
---|---|---|---|---|---|---|---|
05/22/1984 | 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 |
---|---|---|---|---|---|
09/15/2008 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
12/23/2002 | SUPPL-21 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
01/23/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/28/2000 | SUPPL-19 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
04/21/1999 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/23/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/07/1999 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/04/1999 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
04/01/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/18/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/18/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/12/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
10/05/1995 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
08/04/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/06/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/06/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/06/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/05/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
MAXITROL
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 |