Details for New Drug Application (NDA): 201848
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NDA 201848 describes HEPZATO, which is a drug marketed by Delcath Systems Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the HEPZATO profile page.
The generic ingredient in HEPZATO is melphalan hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
The generic ingredient in HEPZATO is melphalan hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
Summary for 201848
| Tradename: | HEPZATO |
| Applicant: | Delcath Systems Inc |
| Ingredient: | melphalan hydrochloride |
| Patents: | 10 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 201848
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848 | NDA | Delcath Systems, Inc. | 75833-601 | 75833-601-01 | 1 KIT in 1 BOX (75833-601-01) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE |
| HEPZATO | melphalan hydrochloride | POWDER;INTRA-ARTERIAL | 201848 | NDA | Delcath Systems, Inc. | 75833-601 | 75833-601-02 | 1 KIT in 1 BOX (75833-601-02) * 5 VIAL, SINGLE-USE in 1 BOX (75833-700-01) / 10 mL in 1 VIAL, SINGLE-USE * 2 BAG in 1 BOX (75833-444-01) / 250 mL in 1 BAG * 5 VIAL, SINGLE-USE in 1 BOX (75833-800-01) / 10 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRA-ARTERIAL | Strength | EQ 50MG BASE/VIAL | ||||
| Approval Date: | Aug 14, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 14, 2030 | ||||||||
| Regulatory Exclusivity Use: | AS A LIVER-DIRECTED TREATMENT FOR ADULT PATIENTS WITH UVEAL MELANOMA WITH UNRESECTABLE HEPATIC METASTASES AFFECTING LESS THAN 50% OF THE LIVER AND NO EXTRAHEPATIC DISEASE OR EXTRAHEPATIC DISEASE LIMITED TO THE BONE, LYMPH NODES, SUBCUTANEOUS TISSUES, OR LUNG THAT IS AMENABLE TO RESECTION OR RADIATION | ||||||||
| Regulatory Exclusivity Expiration: | Aug 14, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 7, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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