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Generated: November 15, 2018

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Details for New Drug Application (NDA): 208751

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NDA 208751 describes FIASP FLEXTOUCH, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the FIASP FLEXTOUCH profile page.

The generic ingredient in FIASP FLEXTOUCH is insulin aspart. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin aspart profile page.
Summary for 208751
Tradename:FIASP FLEXTOUCH
Applicant:Novo Nordisk Inc
Ingredient:insulin aspart
Patents:14
Formulation / Manufacturing:see details
Pharmacology for NDA: 208751
Ingredient-typeInsulin
Suppliers and Packaging for NDA: 208751
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FIASP insulin aspart SOLUTION;IV (INFUSION), SUBCUTANEOUS 208751 NDA Novo Nordisk 0169-3201 0169-3201-11 1 VIAL, GLASS in 1 CARTON (0169-3201-11) > 10 mL in 1 VIAL, GLASS
FIASP FLEXTOUCH insulin aspart SOLUTION;SUBCUTANEOUS 208751 NDA Novo Nordisk 0169-3201 0169-3201-11 1 VIAL, GLASS in 1 CARTON (0169-3201-11) > 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION), SUBCUTANEOUSStrength1000 UNITS/10ML (100 UNITS/ML)
Approval Date:Sep 29, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 29, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Jun 25, 2030Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength300 UNITS/3ML (100 UNITS/ML)
Approval Date:Sep 29, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 29, 2020
Regulatory Exclusivity Use:NEW PRODUCT

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