Details for New Drug Application (NDA): 213278
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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 213278
Tradename: | IRINOTECAN HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | irinotecan hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 213278
Mechanism of Action | Topoisomerase Inhibitors |
Suppliers and Packaging for NDA: 213278
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 213278 | ANDA | Eugia US LLC | 55150-352 | 55150-352-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-352-01) / 2 mL in 1 VIAL, SINGLE-DOSE |
IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 213278 | ANDA | Eugia US LLC | 55150-353 | 55150-353-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-353-01) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/2ML (20MG/ML) | ||||
Approval Date: | Nov 2, 2020 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/5ML (20MG/ML) | ||||
Approval Date: | Nov 2, 2020 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 300MG/15ML (20MG/ML) | ||||
Approval Date: | Nov 2, 2020 | TE: | AP | RLD: | No |
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