Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090101
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 500MG/25ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
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 |
---|---|---|---|---|---|---|---|
11/26/2008 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2013 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
04/29/2013 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
IRINOTECAN HYDROCHLORIDE
INJECTABLE;INJECTION; 500MG/25ML (20MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 500MG/25ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078589 | ACTAVIS TOTOWA |
IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 500MG/25ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213278 | EUGIA PHARMA |
IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 500MG/25ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078796 | HOSPIRA |
IRINOTECAN HYDROCHLORIDE | IRINOTECAN HYDROCHLORIDE | 500MG/25ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 090101 | TEVA PHARMS USA |