Drugs@FDA: FDA-Approved Drugs
Company: CHARTWELL MOLECULES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NILSTAT | NYSTATIN | 100,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
04/14/1971 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/23/1999 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/18/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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07/28/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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07/28/1995 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/16/1995 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/01/1982 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/05/1980 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/25/1978 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/21/1978 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/11/1977 | SUPPL-12 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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12/23/1974 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
07/22/1974 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/15/1974 | SUPPL-9 | Labeling |
Label is not available on this site. |
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02/11/1974 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/22/1974 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/17/1972 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/28/1972 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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07/25/1984 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/02/1984 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/14/1983 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/13/1983 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |