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Generated: November 17, 2018

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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.
Summary for 209112
Tradename:ASCOR
Applicant:Mcguff
Ingredient:ascorbic acid
Patents:0
Formulation / Manufacturing:see details
Generic Entry Opportunity 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;IV (INFUSION)

*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
Ingredient-typeAscorbic Acid
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:RXDosage:SOLUTION;INTRAVENOUSStrength25,000MG/50ML (500MG/ML)
Approval Date:Oct 2, 2017TE: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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