Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062613
Company: PADDOCK LLC
Company: PADDOCK LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NYSTATIN | NYSTATIN | 100% | POWDER;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 |
|---|---|---|---|---|---|---|---|
| 11/26/1985 | 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 |
|---|---|---|---|---|---|
| 03/26/2002 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/27/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/11/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/28/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/04/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/16/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/18/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/03/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 02/03/1995 | SUPPL-1 | Labeling |
Label is not available on this site. |