Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062225
Company: PADAGIS US
Company: PADAGIS US
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 |
---|---|---|---|---|---|---|---|
12/11/1979 | 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 |
---|---|---|---|---|---|
12/03/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
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04/17/2009 | SUPPL-10 | Labeling |
Label is not available on this site. |
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09/05/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/15/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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06/15/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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10/04/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
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07/06/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
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03/18/1988 | SUPPL-3 | 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 |