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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021629

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NDA 021629 describes APIDRA SOLOSTAR, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. There are twenty-one patents protecting this drug. Additional details are available on the APIDRA SOLOSTAR profile page.

The generic ingredient in APIDRA SOLOSTAR is insulin glulisine recombinant. 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 glulisine recombinant profile page.
Summary for 021629
Tradename:APIDRA SOLOSTAR
Applicant:Sanofi Aventis Us
Ingredient:insulin glulisine recombinant
Patents:21
Pharmacology for NDA: 021629
Ingredient-typeInsulin
Suppliers and Packaging for NDA: 021629
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
APIDRA insulin glulisine recombinant INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021629 NDA Sanofi-Aventis U.S. LLC 0088-2500 0088-2500-33 10 mL in 1 VIAL, GLASS (0088-2500-33)
APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629 NDA Sanofi-Aventis U.S. LLC 0088-2500 0088-2500-33 10 mL in 1 VIAL, GLASS (0088-2500-33)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION), SUBCUTANEOUSStrength1000 UNITS/10ML (100 UNITS/ML)
Approval Date:Apr 16, 2004TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Jun 18, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
Patent:➤ SubscribePatent Expiration:Jan 25, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
Patent:➤ SubscribePatent Expiration:Mar 22, 2022Product Flag?YSubstance Flag?Delist Request?

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