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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 203294


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NDA 203294 describes AZITHROMYCIN, which is a drug marketed by Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma Llc, Hainan Poly, Pliva, Sandoz, Taro, Teva Pharms, Zydus, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Mylan Asi, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, ACI, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Cspc Ouyi, Lupin Ltd, Mylan, Sunshine, Teva, Yung Shin Pharm, and Zydus Pharms, and is included in sixty-three NDAs. It is available from fifty-seven 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. Sixty-two suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 203294
Tradename:AZITHROMYCIN
Applicant:Eugia Pharma
Ingredient:azithromycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203294
Medical Subject Heading (MeSH) Categories for 203294
Suppliers and Packaging for NDA: 203294
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin INJECTABLE;INJECTION 203294 ANDA Eugia US LLC 55150-174 55150-174-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-174-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 19, 2015TE:APRLD:No

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