Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202573
Company: CIPLA
Company: CIPLA
| 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 |
|---|---|---|---|---|---|---|---|
| 01/15/2015 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202573Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202573Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2021 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2021 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2021 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2021 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/22/2021 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/15/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202573Orig1s000lbl.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 |