Details for New Drug Application (NDA): 209112
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NDA 209112 describes ASCOR, which is a drug marketed by Mcguff, Fresenius Kabi Usa, and Stira, and is included in three NDAs. It is available from one supplier. Additional details are available on the ASCOR profile page.
The generic ingredient in ASCOR is ascorbic acid. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the ascorbic acid profile page.
The generic ingredient in ASCOR is ascorbic acid. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the ascorbic acid profile page.
Summary for 209112
| Tradename: | ASCOR |
| Applicant: | Mcguff |
| Ingredient: | ascorbic acid |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209112
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ASCOR | ascorbic acid | SOLUTION;INTRAVENOUS | 209112 | NDA | McGuff Pharmaceuticals, Inc. | 67157-101 | 67157-101-50 | 1 VIAL, GLASS in 1 CARTON (67157-101-50) / 50 mL in 1 VIAL, GLASS |
| ASCOR | ascorbic acid | SOLUTION;INTRAVENOUS | 209112 | NDA | McGuff Pharmaceuticals, Inc. | 67157-101 | 67157-101-51 | 25 VIAL, GLASS in 1 TRAY (67157-101-51) / 50 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 25,000MG/50ML (500MG/ML) | ||||
| Approval Date: | Oct 2, 2017 | TE: | AP | RLD: | Yes | ||||
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