Details for New Drug Application (NDA): 215178
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NDA 215178 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 215178
| Tradename: | DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) |
| Applicant: | Lupin |
| Ingredient: | doxorubicin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 215178
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 215178
Suppliers and Packaging for NDA: 215178
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 215178 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-339 | 70748-339-01 | 1 VIAL, SINGLE-USE in 1 CARTON (70748-339-01) / 10 mL in 1 VIAL, SINGLE-USE |
| DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) | doxorubicin hydrochloride | INJECTABLE, LIPOSOMAL;INJECTION | 215178 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-340 | 70748-340-01 | 1 VIAL, SINGLE-USE in 1 CARTON (70748-340-01) / 25 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE, LIPOSOMAL;INJECTION | Strength | 20MG/10ML (2MG/ML) | ||||
| Approval Date: | Jul 16, 2024 | 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: | Jul 16, 2024 | TE: | AB | RLD: | No | ||||
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