Details for New Drug Application (NDA): 078188
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The generic ingredient in IRINOTECAN HYDROCHLORIDE is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.
Summary for 078188
Tradename: | IRINOTECAN HYDROCHLORIDE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | irinotecan hydrochloride |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/2ML (20MG/ML) | ||||
Approval Date: | Feb 27, 2008 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/5ML (20MG/ML) | ||||
Approval Date: | Feb 27, 2008 | TE: | RLD: | No |
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