Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077219
Company: CIPLA LTD
Company: CIPLA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 40MG/2ML (20MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 02/20/2008 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077219s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/15/2023 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/19/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/07/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/07/2016 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/29/2013 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/24/2013 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |