Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062664
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATE | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | EQ 40MG BASE/ML;200,000 UNITS/ML | SOLUTION;IRRIGATION | 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 |
|---|---|---|---|---|---|---|---|
| 04/08/1986 | 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 |
|---|---|---|---|---|---|
| 05/23/2006 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/19/1999 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/02/1999 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/04/1996 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/16/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |