Details for New Drug Application (NDA): 209379
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NDA 209379 describes SELENIOUS ACID, which is a drug marketed by Am Regent, Aspiro, Cipla, Fresenius Kabi Usa, Gland, Kindos, Stira, Sun Pharm, and Zydus Pharms, and is included in nine NDAs. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the SELENIOUS ACID profile page.
The generic ingredient in SELENIOUS ACID is selenious acid. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the selenious acid profile page.
The generic ingredient in SELENIOUS ACID is selenious acid. There is one drug master file entry for this compound. Two suppliers are 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: | AP | RLD: | Yes | ||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 1, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | 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: | ⤷ Start Trial | Patent Expiration: | Jul 1, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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