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Last Updated: January 23, 2021

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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 seven 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. Forty-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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021774
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 0024-5521 0024-5521-31 100 TABLET, COATED in 1 BOTTLE (0024-5521-31)
Paragraph IV (Patent) Challenges for 021774
Tradename Dosage Ingredient NDA Submissiondate
AMBIEN CR TABLET, EXTENDED RELEASE;ORAL zolpidem tartrate 021774 2006-02-24
AMBIEN CR TABLET, EXTENDED RELEASE;ORAL zolpidem tartrate 021774 2006-01-19

Profile for product number 001

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

Profile for product number 002

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

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

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