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Generated: November 21, 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-three drug master file entries for this compound. Sixty-three 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
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 0024-5501-10 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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12.5MG
Approval Date:Sep 2, 2005TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jun 1, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

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

Expired US Patents for NDA 021774

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

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