Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062124
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 09/23/1982 | 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 |
|---|---|---|---|---|---|
| 12/06/2001 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/07/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/03/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/11/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/11/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
NYSTATIN
OINTMENT;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 | OINTMENT;TOPICAL | Prescription | No | AT | 062840 | ACTAVIS MID ATLANTIC |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | No | AT | 209114 | COSETTE |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | No | AT | 062124 | FOUGERA PHARMS |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | No | AT | 209082 | LYNE |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | No | AT | 213826 | MACLEODS PHARMS LTD |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | No | AT | 062472 | PADAGIS US |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | OINTMENT;TOPICAL | Prescription | No | AT | 207767 | ZYDUS LIFESCIENCES |