Details for New Drug Application (NDA): 212993
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NDA 212993 describes IRINOTECAN HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Chartwell Rx, Cipla Ltd, Emcure Pharms Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Hengrui Pharma, Hikma, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Intas Pharms Usa, Novast Labs, Pharmobedient, Pliva Lachema, Qilu Pharm Hainan, Sandoz, Shilpa, Sun Pharma Global, and Teva Pharms Usa, and is included in twenty-six NDAs. It is available from fourteen suppliers. Additional details are available on the IRINOTECAN HYDROCHLORIDE profile page.
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.
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 |
| Ingredient: | irinotecan hydrochloride |
| Patents: | 0 |
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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