Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208485
Company: MEITHEAL
Company: MEITHEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYTARABINE | CYTARABINE | 20MG/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 |
---|---|---|---|---|---|---|---|
02/28/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CYTARABINE
INJECTABLE;INJECTION; 20MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 071868 | HOSPIRA |
CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 072168 | HOSPIRA |
CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 072945 | HOSPIRA |
CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 208485 | MEITHEAL |
CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 200915 | RISING |