Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091203
Company: CIPLA LIMITED
Company: CIPLA LIMITED
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOPINAVIR; RITONAVIR | LOPINAVIR; RITONAVIR | 80MG; 20MG | SOLUTION; ORAL | None (Tentative Approval) | None | 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 |
---|---|---|---|---|---|---|---|
06/29/2012 | ORIG-1 | Tentative Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091203s000TAltr.pdf |