Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062512
Company: WOCKHARDT BIO AG
Company: WOCKHARDT BIO AG
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/29/1984 | 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 |
---|---|---|---|---|---|
03/20/2002 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
07/11/1997 | SUPPL-15 | Labeling |
Label is not available on this site. |
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09/03/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
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10/20/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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09/30/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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03/11/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
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03/25/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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01/10/1989 | SUPPL-9 | 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 |