Details for New Drug Application (NDA): 212937
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The generic ingredient in PEDMARK is sodium thiosulfate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium thiosulfate profile page.
Summary for 212937
Tradename: | PEDMARK |
Applicant: | Fennec Pharms Inc |
Ingredient: | sodium thiosulfate |
Patents: | 7 |
Suppliers and Packaging for NDA: 212937
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PEDMARK | sodium thiosulfate | SOLUTION;INTRAVENOUS | 212937 | NDA | Fennec Pharmaceuticals Inc. | 73077-010 | 73077-010-01 | 1 VIAL, SINGLE-DOSE in 1 BOX, UNIT-DOSE (73077-010-01) / 100 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 12.5GM/100ML (125MG/ML) | ||||
Approval Date: | Sep 20, 2022 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Sep 20, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Regulatory Exclusivity Expiration: | Sep 20, 2029 | ||||||||
Regulatory Exclusivity Use: | TO REDUCE THE RISK OF OTOTOXICITY ASSOCIATED WITH CISPLATIN IN PEDIATRIC PATIENTS 1 MONTH OF AGE AND OLDER WITH LOCALIZED, NON-METASTATIC SOLID TUMORS | ||||||||
Patent: | 10,596,190 | Patent Expiration: | Jan 5, 2038 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patented Use: | A METHOD OF REDUCING OTOTOXICITY IN A HUMAN PEDIATRIC PATIENT ABOUT 5 YEARS OF AGE OR UNDER WITH LOCALIZED MEDULLOBLASTOMA COMPRISING ADMINISTERING SODIUM THIOSULFATE ABOUT SIX HOURS AFTER ADMINISTRATION OF CISPLATIN |
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