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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 050810

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NDA 050810 describes AZASITE, which is a drug marketed by Thea Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the AZASITE profile page.

The generic ingredient in AZASITE 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 050810

Tradename:	AZASITE
Applicant:	Thea Pharma
Ingredient:	azithromycin
Patents:	0

Pharmacology for NDA: 050810

Medical Subject Heading (MeSH) Categories for 050810

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 050810

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810	NDA	Thea Pharma Inc.	82584-307	82584-307-02	1 BOTTLE, DROPPER in 1 CARTON (82584-307-02) / 2.5 mL in 1 BOTTLE, DROPPER
AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810	NDA	Thea Pharma Inc.	82584-307	82584-307-03	1 BOTTLE, DROPPER in 1 CARTON (82584-307-03) / 2.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	1%
Approval Date:	Apr 27, 2007	TE:		RLD:	Yes

Expired US Patents for NDA 050810

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	5,192,535	⤷ Get Started Free
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	7,056,893	⤷ Get Started Free
Thea Pharma	AZASITE	azithromycin	SOLUTION/DROPS;OPHTHALMIC	050810-001	Apr 27, 2007	6,569,443	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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