Details for New Drug Application (NDA): 021997

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NDA 021997 describes EDLUAR, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EDLUAR profile page.

The generic ingredient in EDLUAR is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for 021997

Tradename:	EDLUAR
Applicant:	Mylan Speciality Lp
Ingredient:	zolpidem tartrate
Patents:	2

Pharmacology for NDA: 021997

Mechanism of Action	GABA A Agonists
Physiological Effect	Central Nervous System Depression

Suppliers and Packaging for NDA: 021997

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997	NDA	Meda Pharmaceuticals Inc.	0037-6010	0037-6010-02	20 BLISTER PACK in 1 BOX, UNIT-DOSE (0037-6010-02) / 2 TABLET in 1 BLISTER PACK
EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997	NDA	Meda Pharmaceuticals Inc.	0037-6010	0037-6010-93	5 BLISTER PACK in 1 CARTON (0037-6010-93) / 6 TABLET in 1 BLISTER PACK (0037-6010-35)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;SUBLINGUAL			Strength	5MG
Approval Date:	Mar 13, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 25, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
Patent:	⤷ Sign Up	Patent Expiration:	Apr 6, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;SUBLINGUAL			Strength	10MG
Approval Date:	Mar 13, 2009	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Feb 25, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET

Expired US Patents for NDA 021997

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-002	Mar 13, 2009	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-002	Mar 13, 2009	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	EDLUAR	zolpidem tartrate	TABLET;SUBLINGUAL	021997-001	Mar 13, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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