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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-eight 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 NDA: 205692

Tradename:
BASAGLAR
Applicant:
Eli Lilly And Co
Ingredient:
insulin glargine
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 205692

Ingredient-typeInsulin

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 0002-7711 0002-7711-59 5 SYRINGE in 1 CARTON (0002-7711-59) > 3 mL in 1 SYRINGE (0002-7711-01)
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)

Summary 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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