Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215738
Company: HAINAN POLY
Company: HAINAN POLY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUCONAZOLE | FLUCONAZOLE | 200MG/5ML | FOR 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 |
---|---|---|---|---|---|---|---|
09/21/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
FLUCONAZOLE
FOR SUSPENSION;ORAL; 200MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DIFLUCAN | FLUCONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020090 | PFIZER |
FLUCONAZOLE | FLUCONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 079150 | AUROBINDO PHARMA |
FLUCONAZOLE | FLUCONAZOLE | 200MG/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 215738 | HAINAN POLY |