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Generated: October 20, 2018

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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-three 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 forty 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:23
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:➤ Try a Free TrialPatent Expiration:Jun 18, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
Patent:➤ Try a Free TrialPatent Expiration:Jan 25, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
Patent:➤ Try a Free TrialPatent Expiration:Mar 22, 2022Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021629

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021629-002 Dec 20, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021629-001 Apr 16, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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