Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062876
Company: TARO
Company: TARO
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 |
---|---|---|---|---|---|---|---|
02/29/1988 | 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 |
---|---|---|---|---|---|
07/23/2007 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/04/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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07/10/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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06/30/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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05/10/1989 | SUPPL-5 | Manufacturing (CMC) |
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 | 062832 | MLV |
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 |