Details for New Drug Application (NDA): 212299
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NDA 212299 describes DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), which is a drug marketed by Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences, and is included in six NDAs. It is available from seven 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
Summary for 212299
| Tradename: | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
| Applicant: | Zydus Lifesciences |
| Ingredient: | doxorubicin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 212299
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 212299
Suppliers and Packaging for NDA: 212299
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 212299 | ANDA | Zydus Lifesciences Limited | 49315-008 | 49315-008-03 | 1 VIAL, SINGLE-DOSE in 1 CARTON (49315-008-03) / 10 mL in 1 VIAL, SINGLE-DOSE |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 212299 | ANDA | Zydus Lifesciences Limited | 49315-009 | 49315-009-07 | 1 VIAL, SINGLE-DOSE in 1 CARTON (49315-009-07) / 25 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: | Sep 10, 2020 | 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: | Sep 10, 2020 | TE: | AB | RLD: | No | ||||
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