Details for New Drug Application (NDA): 022100

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NDA 022100 describes AZOR, which is a drug marketed by Cosette and is included in one NDA. It is available from two suppliers. Additional details are available on the AZOR profile page.

The generic ingredient in AZOR is amlodipine besylate; olmesartan medoxomil. There are fifty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; olmesartan medoxomil profile page.

Summary for 022100

Tradename:	AZOR
Applicant:	Cosette
Ingredient:	amlodipine besylate; olmesartan medoxomil
Patents:	0

Pharmacology for NDA: 022100

Mechanism of Action	Angiotensin 2 Receptor Antagonists Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Suppliers and Packaging for NDA: 022100

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100	NDA	Cosette Pharmaceuticals, Inc.	0713-0870	0713-0870-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0870-30)
AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100	NDA	Cosette Pharmaceuticals, Inc.	0713-0871	0713-0871-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0871-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;20MG
Approval Date:	Sep 26, 2007	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;40MG
Approval Date:	Sep 26, 2007	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE;20MG
Approval Date:	Sep 26, 2007	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022100

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-001	Sep 26, 2007	5,616,599*PED	⤷ Get Started Free
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-004	Sep 26, 2007	5,616,599*PED	⤷ Get Started Free
Cosette	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-003	Sep 26, 2007	5,616,599*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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