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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 209999

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NDA 209999 describes AZITHROMYCIN, which is a drug marketed by Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Epic Pharma Llc, Pliva, Sandoz, Taro, Teva Pharms, Zhejiang Poly Pharm, Zydus Lifesciences, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Pharmobedient, Rising, Slate Run Pharma, Sun Pharm Inds Ltd, Teva Parenteral, Alembic, Apotex Corp, Aurobindo Pharma Usa, Bionpharma, Cspc Ouyi, Extrovis, Lupin Ltd, Strides Pharma, Sunshine, Teva, Yung Shin Pharm, and Zydus Pharms, and is included in sixty-three NDAs. It is available from fifty-nine 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-three suppliers are listed for this compound. Additional details are available on the azithromycin profile page.

Summary for 209999

Tradename:	AZITHROMYCIN
Applicant:	Bionpharma
Ingredient:	azithromycin
Patents:	0

Pharmacology for NDA: 209999

Medical Subject Heading (MeSH) Categories for 209999

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 209999

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AZITHROMYCIN	azithromycin	TABLET;ORAL	209999	ANDA	Bionpharma Inc.	69452-173	69452-173-13	30 TABLET, FILM COATED in 1 BOTTLE (69452-173-13)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 600MG BASE
Approval Date:	Dec 26, 2018	TE:	AB	RLD:	No

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