Details for New Drug Application (NDA): 219199
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NDA 219199 describes DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), which is a drug marketed by Alembic, Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences, and is included in seven NDAs. It is available from nine suppliers. Additional details are available on the DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) profile page.
The generic ingredient in DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
The generic ingredient in DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
Summary for 219199
| Tradename: | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
| Applicant: | Alembic |
| Ingredient: | doxorubicin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 219199
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 219199
Suppliers and Packaging for NDA: 219199
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 219199 | ANDA | Alembic Pharmaceuticals Limited | 46708-525 | 46708-525-25 | 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-525-25) / 25 mL in 1 VIAL, SINGLE-DOSE |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 219199 | ANDA | Alembic Pharmaceuticals Limited | 46708-810 | 46708-810-10 | 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-810-10) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE, LIPOSOMAL;INJECTION | Strength | 20MG/10ML (2MG/ML) | ||||
| Approval Date: | Jun 27, 2025 | 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: | Jun 27, 2025 | TE: | AB | RLD: | No | ||||
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