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Serving hundreds of leading biopharmaceutical companies globally:

US Army
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Chinese Patent Office
Fish and Richardson
Daiichi Sankyo

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065246

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NDA 065246 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 065246
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065246
Medical Subject Heading (MeSH) Categories for 065246
Suppliers and Packaging for NDA: 065246
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065246 ANDA Teva Pharmaceuticals USA, Inc. 0093-2026 N 0093-2026-23
AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065246 ANDA Teva Pharmaceuticals USA, Inc. 0093-2026 N 0093-2026-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 200MG BASE/5ML
Approval Date:Jul 5, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 100MG BASE/5ML
Approval Date:Jul 5, 2006TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Federal Trade Commission
Queensland Health
Farmers Insurance

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