Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061578
Company: X GEN PHARMS
Company: X GEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POLY-RX | POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | POWDER;FOR RX COMPOUNDING | 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 |
|---|---|---|---|---|---|---|---|
| 01/05/1972 | 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 |
|---|---|---|---|---|---|
| 12/06/2001 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 04/27/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/1999 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/20/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |