Details for New Drug Application (NDA): 074513
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NDA 074513 describes ETOPOSIDE, which is a drug marketed by Mylan, Accord Hlthcare, Dash Pharms, Dash Pharms Natco, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, 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 five 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the etoposide profile page.
Summary for 074513
| Tradename: | ETOPOSIDE |
| Applicant: | Accord Hlthcare |
| Ingredient: | etoposide |
| Patents: | 0 |
Pharmacology for NDA: 074513
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 074513
Suppliers and Packaging for NDA: 074513
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETOPOSIDE | etoposide | INJECTABLE;INJECTION | 074513 | ANDA | Accord Healthcare Inc. | 16729-114 | 16729-114-08 | 1 VIAL, MULTI-DOSE in 1 BOX (16729-114-08) / 25 mL in 1 VIAL, MULTI-DOSE |
| ETOPOSIDE | etoposide | INJECTABLE;INJECTION | 074513 | ANDA | Accord Healthcare Inc. | 16729-114 | 16729-114-11 | 1 VIAL, MULTI-DOSE in 1 BOX (16729-114-11) / 50 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
| Approval Date: | Mar 14, 1996 | TE: | AP | RLD: | No | ||||
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