Details for New Drug Application (NDA): 209379
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NDA 209379 describes SELENIOUS ACID, which is a drug marketed by Am Regent and is included in one NDA. It is available from one supplier. Additional details are available on the SELENIOUS ACID profile page.
The generic ingredient in SELENIOUS ACID is selenious acid. One supplier is listed for this compound. Additional details are available on the selenious acid profile page.
The generic ingredient in SELENIOUS ACID is selenious acid. One supplier is listed for this compound. Additional details are available on the selenious acid profile page.
Summary for 209379
| Tradename: | SELENIOUS ACID |
| Applicant: | Am Regent |
| Ingredient: | selenious acid |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209379
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SELENIOUS ACID | selenious acid | SOLUTION;INTRAVENOUS | 209379 | NDA | American Regent, Inc. | 0517-6502 | 0517-6502-10 | 10 VIAL, SINGLE-DOSE in 1 BOX (0517-6502-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-6502-01) |
| SELENIOUS ACID | selenious acid | SOLUTION;INTRAVENOUS | 209379 | NDA | American Regent, Inc. | 0517-6560 | 0517-6560-05 | 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0517-6560-05) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (0517-6560-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | ||||
| Approval Date: | Apr 30, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 30, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) | ||||
| Approval Date: | Jan 25, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 30, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | ||||
| Approval Date: | Aug 30, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 30, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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