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 one supplier. 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. Forty-five 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

Pharmacology for NDA: 019908

Mechanism of Action	GABA A Receptor Positive Modulators
Physiological Effect	Central 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:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Dec 16, 1992	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 16, 1992	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019908

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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	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908-002	Dec 16, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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