Details for New Drug Application (NDA): 219881
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NDA 219881 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 nine suppliers. Additional details are available on the DOXORUBICIN HYDROCHLORIDE profile page.
The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries 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 are seventeen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
Summary for 219881
| Tradename: | DOXORUBICIN HYDROCHLORIDE |
| Applicant: | Qilu Pharm Hainan |
| Ingredient: | doxorubicin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 219881
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 219881
Suppliers and Packaging for NDA: 219881
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 219881 | ANDA | Sagent Pharmaceuticals | 25021-263 | 25021-263-10 | 1 VIAL in 1 CARTON (25021-263-10) / 10 mL in 1 VIAL |
| DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 219881 | ANDA | Sagent Pharmaceuticals | 25021-263 | 25021-263-25 | 1 VIAL in 1 CARTON (25021-263-25) / 25 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE, LIPOSOMAL;INJECTION | Strength | 20MG/10ML (2MG/ML) | ||||
| Approval Date: | Feb 3, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE, LIPOSOMAL;INJECTION | Strength | 50MG/25ML (2MG/ML) | ||||
| Approval Date: | Feb 3, 2026 | TE: | AB | RLD: | No | ||||
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