Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210856
Company: HISUN PHARM HANGZHOU
Company: HISUN PHARM HANGZHOU
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLADRIBINE | CLADRIBINE | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
11/25/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CLADRIBINE
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLADRIBINE | CLADRIBINE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076571 | FRESENIUS KABI USA |
CLADRIBINE | CLADRIBINE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075405 | HIKMA |
CLADRIBINE | CLADRIBINE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 210856 | HISUN PHARM HANGZHOU |