Details for New Drug Application (NDA): 209376
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The generic ingredient in TRALEMENT is cupric sulfate; manganese sulfate; selenious acid; zinc sulfate. One supplier is listed for this compound. Additional details are available on the cupric sulfate; manganese sulfate; selenious acid; zinc sulfate profile page.
Summary for 209376
Tradename: | TRALEMENT |
Applicant: | Am Regent |
Ingredient: | cupric sulfate; manganese sulfate; selenious acid; zinc sulfate |
Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209376
Generic Entry Date for 209376*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 209376
Mechanism of Action | Magnetic Resonance Contrast Activity |
Physiological Effect | Decreased Copper Ion Absorption |
Suppliers and Packaging for NDA: 209376
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MULTRYS | cupric sulfate; manganese sulfate; selenious acid; zinc sulfate | SOLUTION;INTRAVENOUS | 209376 | NDA | American Regent, Inc. | 0517-9302 | 0517-9302-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9302-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9302-01) |
TRALEMENT | cupric sulfate; manganese sulfate; selenious acid; zinc sulfate | SOLUTION;INTRAVENOUS | 209376 | NDA | American Regent, Inc. | 0517-9302 | 0517-9302-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9302-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9302-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML) | ||||
Approval Date: | Jul 2, 2020 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Apr 30, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 1, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML) | ||||
Approval Date: | Dec 2, 2020 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Apr 30, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY |
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