FDA.reportPublic FDA data

Application 020911

Type
NDA
Sponsor
TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QVAR 80BECLOMETHASONE DIPROPIONATEAEROSOL, METERED;INHALATION0.08MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002QVAR 40BECLOMETHASONE DIPROPIONATEAEROSOL, METERED;INHALATION0.04MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1342QVARBeclomethasone DipropionateA-S Medication SolutionsNDACurrent
50090-3033QVARBeclomethasone DipropionateA-S Medication SolutionsNDACurrent
59310-202QVARBeclomethasone DipropionateTeva Respiratory, LLCNDACurrent
59310-202QVARBeclomethasone DipropionateTeva Respiratory, LLCNDACurrent
59310-204QVARBeclomethasone DipropionateTeva Respiratory, LLCNDACurrent
59310-204QVARBeclomethasone DipropionateTeva Respiratory, LLCNDACurrent
68071-1691QVARBeclomethasone DipropionateNuCare Pharmaceuticals,Inc.NDACurrent
68788-7025QVARbeclomethasone dipropionatePreferred Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64279SUPPL2020-08-13
64278SUPPL2020-08-13
49932SUPPL2017-10-03
49931SUPPL2017-10-03
49913SUPPL2017-10-03
49912SUPPL2017-10-03
35631SUPPL2014-07-30
3727SUPPL2014-07-24
13727SUPPL2014-05-28
3728SUPPL2014-05-23
3726SUPPL2012-08-01
35630SUPPL2012-07-30
35629SUPPL2008-08-26
3725SUPPL2008-08-20
35628SUPPL2007-01-16
3724SUPPL2006-11-22
13726ORIG2004-06-14
3722ORIG2004-06-14
41806ORIG2004-02-11
26177SUPPL2003-08-15
3723SUPPL2002-05-09