Details for New Drug Application (NDA): 063277
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The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
Summary for 063277
Tradename: | DOXORUBICIN HYDROCHLORIDE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | doxorubicin hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 063277
Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 063277
Suppliers and Packaging for NDA: 063277
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 063277 | ANDA | Fresenius Kabi USA, LLC | 63323-101 | 63323-101-61 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-101-61) / 100 mL in 1 VIAL, MULTI-DOSE |
DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 063277 | ANDA | Fresenius Kabi USA, LLC | 63323-883 | 63323-883-05 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-05) / 5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2MG/ML | ||||
Approval Date: | Oct 26, 1995 | TE: | AP | RLD: | No |
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