Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211607
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TASIMELTEON | TASIMELTEON | 20MG | 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 |
---|---|---|---|---|---|---|---|
12/20/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211607Orig1s000ltr.pdf |
TASIMELTEON
CAPSULE;ORAL; 20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
HETLIOZ | TASIMELTEON | 20MG | CAPSULE;ORAL | Prescription | Yes | AB | 205677 | VANDA PHARMS INC |
TASIMELTEON | TASIMELTEON | 20MG | CAPSULE;ORAL | Prescription | No | AB | 211607 | APOTEX |
TASIMELTEON | TASIMELTEON | 20MG | CAPSULE;ORAL | Prescription | No | AB | 211654 | MSN |
TASIMELTEON | TASIMELTEON | 20MG | CAPSULE;ORAL | Prescription | No | AB | 211601 | TEVA PHARMS USA INC |