Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061229
Company: MONARCH PHARMS
Company: MONARCH PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POLYSPORIN | BACITRACIN ZINC; POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons** | OINTMENT;OPHTHALMIC | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 04/16/1974 | 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 |
|---|---|---|---|---|---|
| 01/31/2006 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 07/23/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/04/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/04/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/20/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/10/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 08/10/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/10/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |