Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062457
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
07/28/1983 | 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 |
---|---|---|---|---|---|
04/27/1993 | SUPPL-21 | Labeling |
Label is not available on this site. |
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08/06/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
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04/29/1992 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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02/24/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
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06/30/1989 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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11/16/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |