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Last Updated: November 4, 2024

Pharmaceutical drugs supplied by: Bayer Healthcare LLC.

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Bayer Healthcare LLC.

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872	NDA	Bayer HealthCare LLC.	0280-0065-01	60 CARTON in 1 BOTTLE (0280-0065-01) / 1 SPRAY, METERED in 1 CARTON	2022-06-27
Bayer Hlthcare	CHILDREN'S ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872	NDA	Bayer HealthCare LLC.	0280-0065-01	60 CARTON in 1 BOTTLE (0280-0065-01) / 1 SPRAY, METERED in 1 CARTON	2022-06-27
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872	NDA	Bayer HealthCare LLC.	0280-0065-02	120 CARTON in 1 BOTTLE (0280-0065-02) / 1 SPRAY, METERED in 1 CARTON	2022-06-27
Bayer Hlthcare	CHILDREN'S ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872	NDA	Bayer HealthCare LLC.	0280-0065-02	120 CARTON in 1 BOTTLE (0280-0065-02) / 1 SPRAY, METERED in 1 CARTON	2022-06-27
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872	NDA	Bayer HealthCare LLC.	0280-0065-03	120 PACKAGE in 1 BOTTLE (0280-0065-03) / 3 SPRAY, METERED in 1 PACKAGE	2022-06-27
Bayer Hlthcare	CHILDREN'S ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872	NDA	Bayer HealthCare LLC.	0280-0065-03	120 PACKAGE in 1 BOTTLE (0280-0065-03) / 3 SPRAY, METERED in 1 PACKAGE	2022-06-27
Bayer Hlthcare	ASTEPRO ALLERGY	azelastine hydrochloride	SPRAY, METERED;NASAL	213872	NDA	Bayer HealthCare LLC.	0280-0065-04	200 CARTON in 1 BOTTLE (0280-0065-04) / 1 SPRAY, METERED in 1 CARTON	2022-06-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

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