Details for New Drug Application (NDA): 209379
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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: | 2 |
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 | |||||
Patent: | ⤷ Try for Free | Patent Expiration: | Jul 1, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Try for Free | Patent Expiration: | Jul 1, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | ADULT AND PEDIATRIC PATIENTS AS A SOURCE OF SELENIUM FOR PARENTERAL NUTRITION WHEN ORAL OR ENTERAL NUTRITION IS NOT POSSIBLE, INSUFFICIENT, OR CONTRAINDICATED |
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: | AP | RLD: | Yes | ||||
Patent: | ⤷ Try for Free | Patent Expiration: | Jul 1, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? |
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