Details for New Drug Application (NDA): 203380
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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 203380
Tradename: | IRINOTECAN HYDROCHLORIDE |
Applicant: | Qilu Pharm Hainan |
Ingredient: | irinotecan hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 203380
Mechanism of Action | Topoisomerase Inhibitors |
Suppliers and Packaging for NDA: 203380
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 203380 | ANDA | Apotex Corp. | 60505-6128 | 60505-6128-0 | 1 VIAL, SINGLE-USE in 1 CARTON (60505-6128-0) / 2 mL in 1 VIAL, SINGLE-USE |
IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 203380 | ANDA | Apotex Corp. | 60505-6128 | 60505-6128-1 | 1 VIAL, SINGLE-USE in 1 CARTON (60505-6128-1) / 5 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/2ML (20MG/ML) | ||||
Approval Date: | May 3, 2016 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/5ML (20MG/ML) | ||||
Approval Date: | May 3, 2016 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 300MG/15ML (20MG/ML) | ||||
Approval Date: | May 3, 2016 | TE: | AP | RLD: | No |
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