Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064042
Company: PAI HOLDINGS
Company: PAI HOLDINGS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 02/28/1994 | 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 |
|---|---|---|---|---|---|
| 09/18/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/18/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/22/1998 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/01/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 01/29/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |