Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050567
Company: ALLERGAN
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POLYTRIM | POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS;OPHTHALMIC | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 10/20/1988 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/19/2003 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 04/12/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/2001 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/18/2000 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/05/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/04/1998 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/02/1998 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/19/1998 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/23/1997 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/31/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/02/1996 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/17/1993 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/08/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 07/02/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |