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-type	Insulin

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:	RX	Dosage:	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS			Strength	1000 UNITS/10ML (100 UNITS/ML)
Approval Date:	Apr 16, 2004	TE:		RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Jun 18, 2018	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
Patent:	➤ Sign Up	Patent Expiration:	Jan 25, 2023	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
Patent:	➤ Sign Up	Patent Expiration:	Mar 22, 2022	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021629

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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	➤ Sign Up	➤ Sign Up
Sanofi Aventis Us	APIDRA SOLOSTAR	insulin glulisine recombinant	INJECTABLE;SUBCUTANEOUS	021629-003	Feb 24, 2009	➤ Sign Up	➤ Sign Up
Sanofi Aventis Us	APIDRA	insulin glulisine recombinant	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021629-002	Dec 20, 2005	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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