Details for New Drug Application (NDA): 074983
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NDA 074983 describes ETOPOSIDE, which is a drug marketed by Mylan, Accord Hlthcare, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, Natco Pharma Usa, Pharmachemie Bv, Pierre Fabre, Teva Parenteral, Teva Pharms Usa, Watson Labs, and Watson Labs Inc, and is included in fifteen NDAs. It is available from six suppliers. Additional details are available on the ETOPOSIDE profile page.
The generic ingredient in ETOPOSIDE is etoposide. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the etoposide profile page.
The generic ingredient in ETOPOSIDE is etoposide. There are eleven drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the etoposide profile page.
Summary for 074983
| Tradename: | ETOPOSIDE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | etoposide |
| Patents: | 0 |
Pharmacology for NDA: 074983
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 074983
Suppliers and Packaging for NDA: 074983
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETOPOSIDE | etoposide | INJECTABLE;INJECTION | 074983 | ANDA | Fresenius Kabi USA, LLC | 63323-104 | 63323-104-05 | 10 BOX in 1 CARTON (63323-104-05) / 1 VIAL, MULTI-DOSE in 1 BOX (63323-104-01) / 5 mL in 1 VIAL, MULTI-DOSE |
| ETOPOSIDE | etoposide | INJECTABLE;INJECTION | 074983 | ANDA | Fresenius Kabi USA, LLC | 63323-104 | 63323-104-06 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-104-06) / 5 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
| Approval Date: | Sep 30, 1998 | TE: | AP | RLD: | No | ||||
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