Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214346
Company: LEADING
Company: LEADING
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 | 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 |
---|---|---|---|---|---|---|---|
03/10/2022 | ORIG-1 | Approval | STANDARD |
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 |