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Generated: May 24, 2018

DrugPatentWatch Database Preview

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-two drug master file entries for this compound. Sixty-five 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
Therapeutic Class:	Sedatives/Hypnotics
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021774

Ingredient-type	Pyridines
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	N	0024-5501-10
AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774	NDA	sanofi-aventis U.S. LLC	0024-5501	N	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	021774-001	Sep 2, 2005	➤ Sign Up	➤ Sign Up
Sanofi Aventis Us	AMBIEN CR	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	021774-002	Sep 2, 2005	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.