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Last Updated: October 24, 2019

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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-two 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:22
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;INTRAVENOUS, SUBCUTANEOUS 021629 NDA Sanofi-Aventis U.S. LLC 0088-2500 0088-2500-33 1 VIAL, GLASS in 1 CARTON (0088-2500-33) > 10 mL in 1 VIAL, GLASS
APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629 NDA Sanofi-Aventis U.S. LLC 0088-2500 0088-2500-33 1 VIAL, GLASS in 1 CARTON (0088-2500-33) > 10 mL in 1 VIAL, GLASS

Profile for product number 001

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

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;INTRAVENOUS, SUBCUTANEOUS 021629-001 Apr 16, 2004   Start Trial   Start Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009   Start Trial   Start Trial
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021629-002 Dec 20, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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