Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208890
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RITONAVIR | RITONAVIR | 100MG | 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 |
---|---|---|---|---|---|---|---|
09/17/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208890Orig1s000TAltr.pdf |
RITONAVIR
TABLET;ORAL; 100MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NORVIR | RITONAVIR | 100MG | TABLET;ORAL | Prescription | Yes | AB | 022417 | ABBVIE |
RITONAVIR | RITONAVIR | 100MG | TABLET;ORAL | Prescription | No | AB | 208890 | AMNEAL |
RITONAVIR | RITONAVIR | 100MG | TABLET;ORAL | Prescription | No | AB | 206614 | AUROBINDO PHARMA LTD |
RITONAVIR | RITONAVIR | 100MG | TABLET;ORAL | Prescription | No | AB | 202573 | CIPLA |
RITONAVIR | RITONAVIR | 100MG | TABLET;ORAL | Prescription | No | AB | 203759 | CIPLA |
RITONAVIR | RITONAVIR | 100MG | TABLET;ORAL | Prescription | No | AB | 204587 | HETERO LABS LTD III |