Drugs@FDA: FDA-Approved Drugs
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
05/25/1976 | 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 |
---|---|---|---|---|---|
08/30/2001 | SUPPL-25 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
06/13/1996 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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05/04/1995 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/04/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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12/03/1993 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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12/03/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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12/03/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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12/03/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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08/31/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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08/31/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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10/21/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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10/21/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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10/21/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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10/21/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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04/27/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
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08/09/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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09/25/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
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11/10/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
NYSTATIN
CREAM;TOPICAL; 100,000 UNITS/GM
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 062949 | ACTAVIS MID ATLANTIC |
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 061966 | COSETTE |
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 207733 | CROWN LABS INC |
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 062129 | FOUGERA PHARMS |
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 213566 | MACLEODS PHARMS LTD |
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 062225 | PADAGIS US |
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 064022 | TARO |
NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 212557 | TORRENT |