Details for New Drug Application (NDA): 209112
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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 |
Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209112
Generic Entry Date for 209112*:
Constraining patent/regulatory exclusivity:
FOR TREATMENT OF SCURVY IN ADULT AND PEDIATRIC PATIENTS AGE 5 MONTHS AND OLDER FOR WHOM ORAL ADMINISTRATION IS NOT POSSIBLE, INSUFFICIENT OR CONTRAINDICATED Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 209112
Medical Subject Heading (MeSH) Categories for 209112
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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