Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062670
Company: TEVA
Company: TEVA
| 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 |
|---|---|---|---|---|---|---|---|
| 06/18/1987 | 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 |
|---|---|---|---|---|---|
| 07/15/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/26/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/13/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/29/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/16/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/06/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/08/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/12/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 04/28/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |