Details for New Drug Application (NDA): 077776
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NDA 077776 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 Pharma Ltd, Hengrui Pharma, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Intas Pharms Usa, Novast Labs, Pliva Lachema, Qilu Pharm Hainan, Sandoz, Shilpa, Sun Pharma Global, Teva Pharms Usa, West-ward Pharms Int, and Zennova, 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 077776
| Tradename: | IRINOTECAN HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | irinotecan hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 077776
| Mechanism of Action | Topoisomerase Inhibitors |
Suppliers and Packaging for NDA: 077776
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 077776 | ANDA | Fresenius Kabi USA, LLC | 63323-193 | 63323-193-52 | 1 VIAL in 1 BOX (63323-193-52) / 2 mL in 1 VIAL |
| IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 077776 | ANDA | Fresenius Kabi USA, LLC | 63323-193 | 63323-193-55 | 1 VIAL in 1 BOX (63323-193-55) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/2ML (20MG/ML) | ||||
| Approval Date: | Feb 27, 2008 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/5ML (20MG/ML) | ||||
| Approval Date: | Feb 27, 2008 | TE: | AP | RLD: | No | ||||
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