Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 219930
Company: SUN PHARM INDS INC
Company: SUN PHARM INDS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEFLAZACORT | DEFLAZACORT | 22.75MG/ML | SUSPENSION;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 01/27/2026 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
DEFLAZACORT
SUSPENSION;ORAL; 22.75MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEFLAZACORT | DEFLAZACORT | 22.75MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 220709 | CARNEGIE |
| DEFLAZACORT | DEFLAZACORT | 22.75MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 219930 | SUN PHARM INDS INC |
| DEFLAZACORT | DEFLAZACORT | 22.75MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 217813 | TRIS PHARMA INC |
| DEFLAZACORT | DEFLAZACORT | 22.75MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 216992 | UPSHER SMITH LABS |
| DEFLAZACORT | DEFLAZACORT | 22.75MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 220042 | ZYDUS LIFESCIENCES |
| EMFLAZA | DEFLAZACORT | 22.75MG/ML | SUSPENSION;ORAL | Prescription | Yes | AB | 208685 | PTC THERAP |
| PYQUVI | DEFLAZACORT | 22.75MG/ML | SUSPENSION;ORAL | Prescription | No | AB | 219417 | AUCTA |