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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
Cantor Fitzgerald
Queensland Health

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205692

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NDA 205692 describes BASAGLAR, which is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from one supplier. Additional details are available on the BASAGLAR profile page.

The generic ingredient in BASAGLAR is insulin glargine. There are thirty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glargine profile page.
Summary for 205692
Applicant:Eli Lilly And Co
Ingredient:insulin glargine
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 205692
Medical Subject Heading (MeSH) Categories for 205692
Suppliers and Packaging for NDA: 205692
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BASAGLAR insulin glargine SOLUTION;SUBCUTANEOUS 205692 NDA Eli Lilly and Company 0002-7715 N 0002-7715-59
BASAGLAR insulin glargine SOLUTION;SUBCUTANEOUS 205692 NDA Eli Lilly and Company 0002-7715 N 0002-7715-63

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength300 UNITS/3ML (100 UNITS/ML)
Approval Date:Dec 16, 2015TE:RLD:No
Regulatory Exclusivity Expiration:Dec 16, 2018
Regulatory Exclusivity Use:NEW PRODUCT

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson

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