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Serving leading biopharmaceutical companies globally:

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Generated: December 17, 2017

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 thirteen 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-one drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 021774

Tradename:1
Applicant:1
Ingredient:1
Patents:1
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 021774

Ingredient-typePyridines
Mechanism of ActionGABA A Agonists
Physiological EffectCentral 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 0024-5501-31 100 TABLET, COATED in 1 BOTTLE (0024-5501-31)
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12.5MG
Approval Date:Sep 2, 2005TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Jun 1, 2020Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6.25MG
Approval Date:Sep 2, 2005TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Jun 1, 2020Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021774

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis UsAMBIEN CRzolpidem tartrateTABLET, EXTENDED RELEASE;ORAL021774-001Sep 2, 2005► Subscribe► Subscribe
Sanofi Aventis UsAMBIEN CRzolpidem tartrateTABLET, EXTENDED RELEASE;ORAL021774-002Sep 2, 2005► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Dow
Deloitte
Express Scripts
Chubb
Baxter
Boehringer Ingelheim
Cipla
Moodys
US Army
Johnson and Johnson

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.

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