Details for New Drug Application (NDA): 209376
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NDA 209376 describes TRALEMENT, which is a drug marketed by Am Regent and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the TRALEMENT profile page.
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.
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: | 3 |
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: | ⤷ Sign Up | Patent Expiration: | Jul 1, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 1, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ADULT AND PEDIATRIC PATIENTS WEIGHING AT LEAST 10 KG AS A SOURCE OF ZINC, COPPER, MANGANESE, AND SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED | ||||||||
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