Details for New Drug Application (NDA): 021774

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NDA 021774 describes AMBIEN CR, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from eleven suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the AMBIEN CR profile page.

The generic ingredient in AMBIEN CR is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 021774

Tradename:	AMBIEN CR
Applicant:	Sanofi Aventis Us
Ingredient:	zolpidem tartrate
Patents:	1
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021774

Mechanism of Action	GABA A Agonists
Physiological Effect	Central Nervous System Depression

Suppliers and Packaging for NDA: 021774

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774	NDA	sanofi-aventis U.S. LLC	0024-5501	0024-5501-10	3 BLISTER PACK in 1 CARTON (0024-5501-10) > 10 TABLET, COATED in 1 BLISTER PACK
AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774	NDA	sanofi-aventis U.S. LLC	0024-5501	0024-5501-31	100 TABLET, COATED in 1 BOTTLE (0024-5501-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	12.5MG
Approval Date:	Sep 2, 2005	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Jun 1, 2020	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	6.25MG
Approval Date:	Sep 2, 2005	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Jun 1, 2020	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021774

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-002	Sep 2, 2005	➤ Sign Up	➤ Sign Up
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-001	Sep 2, 2005	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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