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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. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Forty-one suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.

Summary for NDA: 050775

Tradename:
BIAXIN XL
Applicant:
Abbvie
Ingredient:
clarithromycin
Patents:2
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 050775

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIAXIN XL
clarithromycin
TABLET, EXTENDED RELEASE;ORAL 050775 NDA A-S Medication Solutions LLC 54569-4953 54569-4953-0 4 BLISTER PACK in 1 BOX, UNIT-DOSE (54569-4953-0) > 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
BIAXIN XL
clarithromycin
TABLET, EXTENDED RELEASE;ORAL 050775 NDA Physicians Total Care, Inc. 54868-4191 54868-4191-0 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (54868-4191-0)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 3, 2000TE:RLD:No
Patent:6,010,718Patent Expiration:Apr 11, 2017Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF MILD TO MODERATE INFECTION CAUSED ABY SUSCEPTIBLE STRAINS
Patent:6,551,616Patent Expiration:Jun 15, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MILD TO MODERATE INFECTION CAUSED ABY SUSCEPTIBLE STRAINS


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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