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Last Updated: February 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065246


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NDA 065246 describes AZITHROMYCIN, which is a drug marketed by Amneal Pharms Llc, Aurobindo Pharma Ltd, Epic Pharma Llc, Lupin Ltd, Pliva, Sandoz, Taro, Teva Pharms, Zydus, Cspc Ouyi, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly Pharm, Hospira, Mylan Asi, Mylan Labs Ltd, Sun Pharm Inds Ltd, Teva Parenteral, Apotex Corp, Bionpharma Inc, Mylan, Sunshine Lake, Teva, and Wockhardt, and is included in fifty-two NDAs. It is available from forty-eight 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-one 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
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 0093-2026-23 15 mL in 1 BOTTLE (0093-2026-23)
AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065246 ANDA Teva Pharmaceuticals USA, Inc. 0093-2026 0093-2026-31 30 mL in 1 BOTTLE (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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