Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209986
Company: MYLAN LABS LTD
Company: MYLAN LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
COBICISTAT | COBICISTAT | 150MG | TABLET;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 |
---|---|---|---|---|---|---|---|
02/07/2024 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209986Orig1s000ltr.pdf |
COBICISTAT
TABLET;ORAL; 150MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
COBICISTAT | COBICISTAT | 150MG | TABLET;ORAL | Prescription | No | AB | 209986 | MYLAN LABS LTD |
TYBOST | COBICISTAT | 150MG | TABLET;ORAL | Prescription | Yes | AB | 203094 | GILEAD SCIENCES INC |