Details for New Drug Application (NDA): 219633
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NDA 219633 describes SELENIOUS ACID, which is a drug marketed by Am Regent, Aspiro, Cipla, Fresenius Kabi Usa, Gland, and Sun Pharm, and is included in six NDAs. It is available from three 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. Three 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. Three suppliers are listed for this compound. Additional details are available on the selenious acid profile page.
Summary for 219633
| Tradename: | SELENIOUS ACID |
| Applicant: | Aspiro |
| Ingredient: | selenious acid |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219633
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SELENIOUS ACID | selenious acid | SOLUTION;INTRAVENOUS | 219633 | ANDA | Camber Pharmaceuticals, Inc. | 31722-492 | 31722-492-31 | 5 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (31722-492-31) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE (31722-492-10) |
| SELENIOUS ACID | selenious acid | SOLUTION;INTRAVENOUS | 219633 | ANDA | Camber Pharmaceuticals, Inc. | 31722-493 | 31722-493-31 | 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-493-31) / 2 mL in 1 VIAL, SINGLE-DOSE (31722-493-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) | ||||
| Approval Date: | Jun 11, 2025 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) | ||||
| Approval Date: | Jun 11, 2025 | TE: | AP | RLD: | No | ||||
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