Details for New Drug Application (NDA): 091089
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NDA 091089 describes TOPOTECAN HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Meitheal, Novast Labs, Rising, Sagent Pharms, Sun Pharm Inds Ltd, Teyro Labs, Dash Pharms, and Hospira Inc, and is included in fifteen NDAs. It is available from five suppliers. Additional details are available on the TOPOTECAN HYDROCHLORIDE profile page.
The generic ingredient in TOPOTECAN HYDROCHLORIDE is topotecan hydrochloride. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
The generic ingredient in TOPOTECAN HYDROCHLORIDE is topotecan hydrochloride. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.
Summary for 091089
| Tradename: | TOPOTECAN HYDROCHLORIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | topotecan hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 091089
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 091089
Suppliers and Packaging for NDA: 091089
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOPOTECAN HYDROCHLORIDE | topotecan hydrochloride | INJECTABLE;INJECTION | 091089 | ANDA | Fresenius Kabi USA, LLC | 63323-762 | 63323-762-94 | 1 VIAL in 1 BOX (63323-762-94) / 4 mL in 1 VIAL |
| TOPOTECAN HYDROCHLORIDE | topotecan hydrochloride | INJECTABLE;INJECTION | 091089 | ANDA | Fresenius Kabi USA, LLC | 63323-762 | 63323-762-10 | 1 VIAL in 1 BOX (63323-762-10) / 4 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 4MG BASE/VIAL | ||||
| Approval Date: | Nov 29, 2010 | TE: | AP | RLD: | No | ||||
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