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. |
||
| 09/03/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 10/20/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/25/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 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 |