Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213734
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METYROSINE | METYROSINE | 250MG | 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 |
---|---|---|---|---|---|---|---|
07/24/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213734Orig1s000ltr.pdf |
METYROSINE
CAPSULE;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEMSER | METYROSINE | 250MG | CAPSULE;ORAL | Prescription | Yes | AB | 017871 | BAUSCH |
METYROSINE | METYROSINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 213734 | AMNEAL |
METYROSINE | METYROSINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 215541 | LEADING |