Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062517
Company: FOUGERA PHARMS INC
Company: FOUGERA PHARMS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
06/07/1984 | 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 |
---|---|---|---|---|---|
12/14/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
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12/13/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
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01/26/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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06/11/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
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06/23/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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09/27/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
NYSTATIN
SUSPENSION;ORAL; 100,000 UNITS/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION;ORAL | Prescription | No | AA | 062517 | FOUGERA PHARMS INC |
NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION;ORAL | Prescription | No | AA | 065148 | GENUS |
NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION;ORAL | Prescription | No | AA | 214346 | LEADING |
NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION;ORAL | Prescription | No | AA | 203621 | PHARM ASSOC |
NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION;ORAL | Prescription | No | AA | 062876 | TARO |
NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION;ORAL | Prescription | No | AA | 062512 | WOCKHARDT BIO AG |