Details for New Drug Application (NDA): 212993
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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 212993
Tradename: | IRINOTECAN HYDROCHLORIDE |
Applicant: | Gland Pharma Ltd |
Ingredient: | irinotecan hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212993
Mechanism of Action | Topoisomerase Inhibitors |
Suppliers and Packaging for NDA: 212993
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 212993 | ANDA | Northstar Rx LLC | 16714-027 | 16714-027-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-027-01) / 2 mL in 1 VIAL, SINGLE-DOSE |
IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 212993 | ANDA | Northstar Rx LLC | 16714-131 | 16714-131-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16714-131-01) / 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 18, 2019 | 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 18, 2019 | TE: | AP | RLD: | No |
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