Details for New Drug Application (NDA): 063277
NDA 063277 describes DOXORUBICIN HYDROCHLORIDE, which is a drug marketed by Qilu Pharm Hainan, Actavis Inc, Almaject, Amneal, Fresenius Kabi Usa, Gland, Hikma, Hisun Pharm Hangzhou, Hlthcare, Mylan Labs Ltd, Pfizer, Pharmachemie Bv, Pharmobedient, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, Alembic, Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences, and is included in twenty-seven NDAs. It is available from ten suppliers. Additional details are available on the DOXORUBICIN HYDROCHLORIDE profile page.
The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There is one drug master file entry for this compound. Twenty 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 |
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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