Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 207741
Company: DR REDDYS
Company: DR REDDYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT;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 |
|---|---|---|---|---|---|---|---|
| 01/31/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
NYSTATIN AND TRIAMCINOLONE ACETONIDE
OINTMENT;TOPICAL; 100,000 UNITS/GM;0.1%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT;TOPICAL | Prescription | No | AT | 214186 | ALEMBIC |
| NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT;TOPICAL | Prescription | No | AT | 207741 | DR REDDYS |
| NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT;TOPICAL | Prescription | No | AT | 207217 | EPIC PHARMA LLC |
| NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT;TOPICAL | Prescription | No | AT | 062602 | FOUGERA PHARMS INC |
| NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT;TOPICAL | Prescription | No | AT | 214751 | MACLEODS PHARMS LTD |
| NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT;TOPICAL | Prescription | No | AT | 207380 | PADAGIS ISRAEL |
| NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT;TOPICAL | Prescription | No | AT | 206785 | RISING |
| NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT;TOPICAL | Prescription | No | AT | 063305 | SUN PHARMA CANADA |
| NYSTATIN AND TRIAMCINOLONE ACETONIDE | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | OINTMENT;TOPICAL | Prescription | No | AT | 207764 | ZYDUS LIFESCIENCES |