Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090471
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPINAVIR; RITONAVIR | LOPINAVIR; RITONAVIR | 100MG; 25MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| LOPINAVIR; RITONAVIR | LOPINAVIR; RITONAVIR | 200MG; 50MG | TABLET; 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 |
|---|---|---|---|---|---|---|---|
| 03/10/2009 | ORIG-1 | Tentative Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090471s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/07/2020 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |