Details for New Drug Application (NDA): 050775

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NDA 050775 describes BIAXIN XL, which is a drug marketed by Abbvie and is included in one NDA. Additional details are available on the BIAXIN XL profile page.

The generic ingredient in BIAXIN XL is clarithromycin. There are twenty-one drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.

Summary for 050775

Tradename:	BIAXIN XL
Applicant:	Abbvie
Ingredient:	clarithromycin
Patents:	0

Medical Subject Heading (MeSH) Categories for 050775

Anti-Bacterial Agents
Cytochrome P-450 CYP3A Inhibitors
Protein Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 3, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 050775

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	BIAXIN XL	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	050775-001	Mar 3, 2000	6,010,718	⤷ Subscribe
Abbvie	BIAXIN XL	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	050775-001	Mar 3, 2000	6,551,616	⤷ Subscribe
Abbvie	BIAXIN XL	clarithromycin	TABLET, EXTENDED RELEASE;ORAL	050775-001	Mar 3, 2000	6,552,616	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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