FDA.reportPublic FDA data

Application 202813

Type
NDA
Sponsor
TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QNASLBECLOMETHASONE DIPROPIONATEAEROSOL, METERED;NASAL0.08MG/ACTUATIONYesYes
002QNASLBECLOMETHASONE DIPROPIONATEAEROSOL, METERED;NASAL0.04MG/ACTUATIONYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59310-206QNASLBeclomethasone DipropionateTeva Respiratory, LLCNDACurrent
59310-206QNASLBeclomethasone DipropionateTeva Respiratory, LLCNDACurrent
59310-210QNASLBeclomethasone DipropionateTeva Respiratory, LLCNDACurrent
59310-210QNASLBeclomethasone DipropionateTeva Respiratory, LLCNDACurrent
59310-406QNASLBeclomethasone DipropionateTeva Respiratory, LLCNDACurrent
59310-406QNASLBeclomethasone DipropionateTeva Respiratory, LLCNDACurrent
59310-406QNASLBeclomethasone DipropionateTeva Respiratory, LLCNDACurrent
59310-406QNASLBeclomethasone DipropionateTeva Respiratory, LLCNDACurrent
59310-406QNASLBeclomethasone DipropionateTeva Respiratory, LLCNDACurrent
59310-410QNASLBeclomethasone dipropionateTeva Respiratory, LLCNDACurrent
59310-410QNASLBeclomethasone dipropionateTeva Respiratory, LLCNDACurrent
59310-410QNASLBeclomethasone dipropionateTeva Respiratory, LLCNDACurrent
59310-410QNASLBeclomethasone dipropionateTeva Respiratory, LLCNDACurrent
59310-410QNASLBeclomethasone dipropionateTeva Respiratory, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61875SUPPL2020-02-12
49115SUPPL2017-07-28
49088SUPPL2017-07-27
40227SUPPL2014-12-19
19386SUPPL2014-12-19
32317SUPPL2014-12-18
10116SUPPL2014-12-18
10115SUPPL2014-07-11
40226SUPPL2014-03-20
32316SUPPL2014-03-20
44868ORIG2013-06-10
22899ORIG2013-06-10
32315ORIG2012-03-27
19385ORIG2012-03-27
51887SUPPL1900-01-01
51886SUPPL1900-01-01
51885SUPPL1900-01-01