Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Moodys
Merck
Boehringer Ingelheim
Express Scripts
Cantor Fitzgerald
Cipla
Daiichi Sankyo
Healthtrust

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065153

« Back to Dashboard

NDA 065153 describes AZITHROMYCIN, which is a drug marketed by Lupin Ltd, Pliva, Sandoz, Teva Pharms, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Asi, Mylan Labs Ltd, Sun Pharm Inds Ltd, Teva Parenteral, Apotex Corp, Mylan, Teva, and Wockhardt, and is included in thirty-five NDAs. It is available from fifty-one suppliers. Additional details are available on the AZITHROMYCIN profile page.

The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 065153
Tradename:AZITHROMYCIN
Applicant:Teva
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065153
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065153
Suppliers and Packaging for NDA: 065153
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin TABLET;ORAL 065153 ANDA Teva Pharmaceuticals USA, Inc. 0093-7146 N 0093-7146-56
AZITHROMYCIN azithromycin TABLET;ORAL 065153 ANDA Unit Dose Services 50436-4357 N 50436-4357-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Nov 14, 2005TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Johnson and Johnson
Healthtrust
QuintilesIMS
Deloitte
Chinese Patent Office
Farmers Insurance
Cipla
Merck

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.

botpot