Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062949
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | AT | 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 |
|---|---|---|---|---|---|---|---|
| 06/13/1988 | 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 |
|---|---|---|---|---|---|
| 10/03/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/30/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/2000 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/15/2001 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/05/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
NYSTATIN
CREAM;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 | CREAM;TOPICAL | Prescription | No | AT | 062949 | ACTAVIS MID ATLANTIC |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 061966 | COSETTE |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 207733 | CROWN LABS INC |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 062129 | FOUGERA PHARMS |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 213566 | MACLEODS PHARMS LTD |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 062225 | PADAGIS US |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 064022 | TARO |
| NYSTATIN | NYSTATIN | 100,000 UNITS/GM | CREAM;TOPICAL | Prescription | No | AT | 212557 | TORRENT |