Details for New Drug Application (NDA): 201848
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The generic ingredient in HEPZATO is melphalan hydrochloride. There are twelve drug master file entries for this compound. Seventeen 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 |
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: | 10,098,997 | Patent Expiration: | Nov 7, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? |
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