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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
Colorcon
US Army
Federal Trade Commission
McKinsey
Novartis
Moodys
Farmers Insurance
Argus Health

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065382

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NDA 065382 describes CLARITHROMYCIN, which is a drug marketed by Sandoz, Sun Pharm Inds Ltd, Actavis Labs Fl Inc, Allied Pharma Inc, Idt Australia Ltd, Lupin Ltd, Mayne Pharma, Ranbaxy, Apotex Corp, Aurobindo, Hec Pharm Usa Inc, Ivax Sub Teva Pharms, Mylan, Teva, West-ward Pharms Int, and Wockhardt, and is included in twenty NDAs. It is available from thirty-eight 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.

Summary for 065382

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

Medical Subject Heading (MeSH) Categories for 065382

Suppliers and Packaging for NDA: 065382

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITHROMYCIN clarithromycin FOR SUSPENSION;ORAL 065382 ANDA Ranbaxy Pharmaceuticals Inc. 63304-821 63304-821-04 100 mL in 1 BOTTLE (63304-821-04)
CLARITHROMYCIN clarithromycin FOR SUSPENSION;ORAL 065382 ANDA Ranbaxy Pharmaceuticals Inc. 63304-821 63304-821-03 50 mL in 1 BOTTLE (63304-821-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Aug 30, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Aug 30, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Moodys
Fish and Richardson
Julphar
US Army
Argus Health
Baxter
QuintilesIMS
Mallinckrodt
Boehringer Ingelheim
Cipla

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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