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Generated: November 15, 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 forty 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
Tradename:BASAGLAR
Applicant:Eli Lilly And Co
Ingredient:insulin glargine
Patents:0
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 205692
Generic Entry Date for 205692*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
Dosage:
SOLUTION;SUBCUTANEOUS

*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: 205692
Ingredient-typeInsulin
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 0002-7715-59 5 SYRINGE in 1 CARTON (0002-7715-59) > 3 mL in 1 SYRINGE (0002-7715-01)
BASAGLAR insulin glargine SOLUTION;SUBCUTANEOUS 205692 NDA Eli Lilly and Company 0002-7715 0002-7715-63 1 SYRINGE in 1 CARTON (0002-7715-63) > 3 mL in 1 SYRINGE

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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