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Details for New Drug Application (NDA): 065155

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NDA 065155 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-three suppliers are listed for this compound. Additional details are available on the clarithromycin profile page.

Summary for NDA: 065155

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

Suppliers and Packaging for NDA: 065155

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITHROMYCIN
clarithromycin
TABLET;ORAL 065155 ANDA Teva Pharmaceuticals USA Inc 0093-7528 0093-7528-06 60 TABLET, FILM COATED in 1 BOTTLE (0093-7528-06)
CLARITHROMYCIN
clarithromycin
TABLET;ORAL 065155 ANDA Teva Pharmaceuticals USA Inc 0093-7529 0093-7529-06 60 TABLET, FILM COATED in 1 BOTTLE (0093-7529-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:May 31, 2005TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:May 31, 2005TE: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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