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Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065144

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NDA 065144 describes CLARITHROMYCIN, which is a drug marketed by Ranbaxy, Allied Pharma Inc, Lupin Ltd, Sandoz, Ivax Sub Teva Pharms, Actavis Labs Fl Inc, Idt Australia Ltd, Mayne Pharma, Teva, Wockhardt, Sun Pharm Inds Ltd, West-ward Pharms Int, Apotex Corp, Hec Pharm Usa Inc, Aurobindo, and Mylan, and is included in twenty NDAs. It is available from thirty-nine suppliers. Additional details are available on the CLARITHROMYCIN profile page.

The generic ingredient in CLARITHROMYCIN 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: 065144

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 065144

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITHROMYCIN
clarithromycin
TABLET;ORAL 065144 ANDA Sandoz Inc 0781-1961 0781-1961-60 60 TABLET in 1 BOTTLE (0781-1961-60)
CLARITHROMYCIN
clarithromycin
TABLET;ORAL 065144 ANDA Rebel Distributors Corp. 21695-557 21695-557-10 10 TABLET in 1 BOTTLE (21695-557-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Oct 18, 2005TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Johnson and Johnson
Queensland Health
Moodys
Julphar
Mallinckrodt
Merck
Chinese Patent Office
Boehringer Ingelheim

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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