Details for New Drug Application (NDA): 209112
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NDA 209112 describes ASCOR, which is a drug marketed by Mcguff and is included in one NDA. It is available from one supplier. Additional details are available on the ASCOR profile page.
The generic ingredient in ASCOR is ascorbic acid. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ascorbic acid profile page.
The generic ingredient in ASCOR is ascorbic acid. There are six drug master file entries for this compound. One supplier is 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: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 2, 2024 | ||||||||
| Regulatory Exclusivity Use: | FOR TREATMENT OF SCURVY IN ADULT AND PEDIATRIC PATIENTS AGE 5 MONTHS AND OLDER FOR WHOM ORAL ADMINISTRATION IS NOT POSSIBLE, INSUFFICIENT OR CONTRAINDICATED | ||||||||
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