Details for New Drug Application (NDA): 074983
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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 074983
Tradename: | ETOPOSIDE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | etoposide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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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