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Generated: November 17, 2018

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Details for New Drug Application (NDA): 019908

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NDA 019908 describes AMBIEN, which is a drug marketed by Sanofi Aventis Us and is included in two NDAs. It is available from three suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the AMBIEN profile page.

The generic ingredient in AMBIEN 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 019908
Tradename:AMBIEN
Applicant:Sanofi Aventis Us
Ingredient:zolpidem tartrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019908
Ingredient-typePyridines
Mechanism of ActionGABA A Agonists
Physiological EffectCentral Nervous System Depression
Suppliers and Packaging for NDA: 019908
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMBIEN zolpidem tartrate TABLET;ORAL 019908 NDA sanofi-aventis U.S. LLC 0024-5401 0024-5401-31 100 TABLET, FILM COATED in 1 BOTTLE (0024-5401-31)
AMBIEN zolpidem tartrate TABLET;ORAL 019908 NDA sanofi-aventis U.S. LLC 0024-5421 0024-5421-31 100 TABLET, FILM COATED in 1 BOTTLE (0024-5421-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 16, 1992TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 16, 1992TE:ABRLD:Yes

Expired US Patents for NDA 019908

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AMBIEN zolpidem tartrate TABLET;ORAL 019908-001 Dec 16, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us AMBIEN zolpidem tartrate TABLET;ORAL 019908-002 Dec 16, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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