Application 050697

Type: NDA
Sponsor: ABBVIE INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BIAXIN XL	CLARITHROMYCIN	TABLET;ORAL	250MG	No	No
002	BIAXIN XL	CLARITHROMYCIN	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarithromycin	CLARITHROMYCIN	Asclemed USA, Inc.	a12e4d38-e0f8-4467-a26c-bb25a342aa92	2020-10-20	Warnings, Adverse reactions	Name fallback generic name: CLARITHROMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8022	SUPPL	2004-07-21