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Generated: November 17, 2018

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Details for New Drug Application (NDA): 209196

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NDA 209196 describes ADMELOG SOLOSTAR, which is a drug marketed by Sanofi-aventis Us and is included in one NDA. It is available from one supplier. There are nineteen patents protecting this drug. Additional details are available on the ADMELOG SOLOSTAR profile page.

The generic ingredient in ADMELOG SOLOSTAR is insulin lispro. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin lispro profile page.
Summary for 209196
Tradename:ADMELOG SOLOSTAR
Applicant:Sanofi-aventis Us
Ingredient:insulin lispro
Patents:19
Formulation / Manufacturing:see details
Pharmacology for NDA: 209196
Ingredient-typeInsulin
Suppliers and Packaging for NDA: 209196
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADMELOG insulin lispro SOLUTION;IV (INFUSION), SUBCUTANEOUS 209196 NDA Sanofi-Aventis U.S. LLC 0024-5924 0024-5924-10 1 VIAL, MULTI-DOSE in 1 CARTON (0024-5924-10) > 10 mL in 1 VIAL, MULTI-DOSE
ADMELOG SOLOSTAR insulin lispro SOLUTION;IV (INFUSION), SUBCUTANEOUS 209196 NDA Sanofi-Aventis U.S. LLC 0024-5924 0024-5924-10 1 VIAL, MULTI-DOSE in 1 CARTON (0024-5924-10) > 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION), SUBCUTANEOUSStrength1000 UNITS/10ML (100 UNITS/ML)
Approval Date:Dec 11, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 11, 2020
Regulatory Exclusivity Use:NEW PRODUCT

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION), SUBCUTANEOUSStrength300 UNITS/3ML (100 UNITS/ML)
Approval Date:Dec 11, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 11, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Sep 23, 2027Product Flag?YSubstance Flag?Delist Request?

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Cerilliant
Fuji
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Citi
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