Application 207921

Type: NDA
Sponsor: NORTON WATERFORD

Related Records

Company: NORTON WATERFORD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QVAR REDIHALER	BECLOMETHASONE DIPROPIONATE	AEROSOL, METERED;INHALATION	0.04MG/INH	Yes	No
002	QVAR REDIHALER	BECLOMETHASONE DIPROPIONATE	AEROSOL, METERED;INHALATION	0.08MG/INH	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3459	QVAR REDIHALER	Beclomethasone Dipropionate HFA	A-S Medication Solutions	NDA	Current
50090-5031	QVAR REDIHALER	Beclomethasone Dipropionate HFA	A-S Medication Solutions	NDA	Current
50090-5031	QVAR REDIHALER	Beclomethasone Dipropionate HFA	A-S Medication Solutions	NDA	Current
50090-5032	QVAR REDIHALER	Beclomethasone Dipropionate HFA	A-S Medication Solutions	NDA	Current
50090-5032	QVAR REDIHALER	Beclomethasone Dipropionate HFA	A-S Medication Solutions	NDA	Current
53002-2436	QVAR REDIHALER	Beclomethasone Dipropionate HFA	RPK Pharmaceuticals, Inc.	NDA	Current
53002-2436	QVAR REDIHALER	Beclomethasone Dipropionate HFA	RPK Pharmaceuticals, Inc.	NDA	Current
53002-3477	QVAR REDIHALER	Beclomethasone Dipropionate HFA	RPK Pharmaceuticals, Inc.	NDA	Current
53002-3477	QVAR REDIHALER	Beclomethasone Dipropionate HFA	RPK Pharmaceuticals, Inc.	NDA	Current
59310-302	QVAR REDIHALER	Beclomethasone Dipropionate HFA	Teva Respiratory, LLC	NDA	Current
59310-302	QVAR REDIHALER	Beclomethasone Dipropionate HFA	Teva Respiratory, LLC	NDA	Current
59310-302	QVAR REDIHALER	Beclomethasone Dipropionate HFA	Teva Respiratory, LLC	NDA	Current
59310-302	QVAR REDIHALER	Beclomethasone Dipropionate HFA	Teva Respiratory, LLC	NDA	Current
59310-302	QVAR REDIHALER	Beclomethasone Dipropionate HFA	Teva Respiratory, LLC	NDA	Current
59310-302	QVAR REDIHALER	Beclomethasone Dipropionate HFA	Teva Respiratory, LLC	NDA	Current
59310-304	QVAR REDIHALER	Beclomethasone Dipropionate HFA	Teva Respiratory, LLC	NDA	Current
59310-304	QVAR REDIHALER	Beclomethasone Dipropionate HFA	Teva Respiratory, LLC	NDA	Current
59310-304	QVAR REDIHALER	Beclomethasone Dipropionate HFA	Teva Respiratory, LLC	NDA	Current
59310-304	QVAR REDIHALER	Beclomethasone Dipropionate HFA	Teva Respiratory, LLC	NDA	Current
59310-304	QVAR REDIHALER	Beclomethasone Dipropionate HFA	Teva Respiratory, LLC	NDA	Current
59310-304	QVAR REDIHALER	Beclomethasone Dipropionate HFA	Teva Respiratory, LLC	NDA	Current

Documents

Document	Submission type	Date
83595	SUPPL	2025-09-30
83569	SUPPL	2025-09-29
77607	SUPPL	2024-02-23
77604	SUPPL	2024-02-23
65875	SUPPL	2021-01-08
65864	SUPPL	2021-01-07
52667	ORIG	2018-02-16
49256	ORIG	2017-08-07
49250	ORIG	2017-08-04