Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078796
Company: HOSPIRA
Company: HOSPIRA
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/27/2008 | 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 |
---|---|---|---|---|---|
06/19/2020 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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06/19/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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12/27/2017 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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01/02/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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01/24/2013 | SUPPL-4 | 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 |