Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216076
Company: TEVA PHARMS
Company: TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MIDOSTAURIN | MIDOSTAURIN | 25MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
04/29/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216076Orig1s000TAltr.pdf |
MIDOSTAURIN
CAPSULE;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MIDOSTAURIN | MIDOSTAURIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 216015 | LUPIN |
MIDOSTAURIN | MIDOSTAURIN | 25MG | CAPSULE;ORAL | Prescription | No | AB | 216076 | TEVA PHARMS |
RYDAPT | MIDOSTAURIN | 25MG | CAPSULE;ORAL | Prescription | Yes | AB | 207997 | NOVARTIS |