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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065178

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NDA 065178 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 065178

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

Medical Subject Heading (MeSH) Categories for 065178

Suppliers and Packaging for NDA: 065178

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITHROMYCIN clarithromycin TABLET;ORAL 065178 ANDA West-Ward Pharmaceuticals Corp. 0054-0036 0054-0036-21 60 TABLET, COATED in 1 BOTTLE, PLASTIC (0054-0036-21)
CLARITHROMYCIN clarithromycin TABLET;ORAL 065178 ANDA West-Ward Pharmaceuticals Corp. 0054-0037 0054-0037-21 60 TABLET, COATED in 1 BOTTLE, PLASTIC (0054-0037-21)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:May 25, 2004TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:May 25, 2004TE:ABRLD:No


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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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