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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
US Army
AstraZeneca
Baxter
Covington
Mallinckrodt
Chubb
Accenture
Merck

Generated: May 25, 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 Epic Pharma Llc, 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-six NDAs. It is available from fifty-two 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-eight suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 065246
Tradename:AZITHROMYCIN
Applicant:Pliva
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065246
Ingredient-typeMacrolides
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:

Moodys
Teva
Cipla
Argus Health
Boehringer Ingelheim
Fuji
Citi
Julphar
Fish and Richardson

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