FDA.reportPublic FDA data

Application 205636

Type
NDA
Sponsor
TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROAIR RESPICLICKALBUTEROL SULFATEPOWDER, METERED;INHALATIONEQ 0.09MG BASE/INHYesYes
002PROAIR DIGIHALERALBUTEROL SULFATEPOWDER, METERED;INHALATIONEQ 0.09MG BASE/INHYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53002-1750ProAir RespiClickAlbuterol SulfateRPK Pharmaceuticals, Inc.NDACurrent
53002-1750ProAir RespiClickAlbuterol SulfateRPK Pharmaceuticals, Inc.NDACurrent
59310-117ProAir Digihaleralbuterol sulfateTeva Respiratory, LLCNDACurrent
59310-117ProAir Digihaleralbuterol sulfateTeva Respiratory, LLCNDACurrent
59310-117ProAir Digihaleralbuterol sulfateTeva Respiratory, LLCNDACurrent
59310-117ProAir Digihaleralbuterol sulfateTeva Respiratory, LLCNDACurrent
59310-117ProAir Digihaleralbuterol sulfateTeva Respiratory, LLCNDACurrent
59310-117ProAir Digihaleralbuterol sulfateTeva Respiratory, LLCNDACurrent
59310-117ProAir Digihaleralbuterol sulfateTeva Respiratory, LLCNDACurrent
59310-540ProAir DigihalerAlbuterol SulfateTeva Respiratory, LLCNDACurrent
59310-540ProAir DigihalerAlbuterol SulfateTeva Respiratory, LLCNDACurrent
59310-540ProAir DigihalerAlbuterol SulfateTeva Respiratory, LLCNDACurrent
59310-540ProAir DigihalerAlbuterol SulfateTeva Respiratory, LLCNDACurrent
59310-540ProAir DigihalerAlbuterol SulfateTeva Respiratory, LLCNDACurrent
59310-540ProAir DigihalerAlbuterol SulfateTeva Respiratory, LLCNDACurrent
59310-580ProAir RespiClickAlbuterol SulfateTeva Respiratory, LLCNDACurrent
59310-580ProAir RespiClickAlbuterol SulfateTeva Respiratory, LLCNDACurrent
59310-580ProAir RespiClickAlbuterol SulfateTeva Respiratory, LLCNDACurrent
59310-580ProAir RespiClickAlbuterol SulfateTeva Respiratory, LLCNDACurrent
59310-580ProAir RespiClickAlbuterol SulfateTeva Respiratory, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64774SUPPL2020-10-01
64763SUPPL2020-09-30
57161SUPPL2019-01-09
57160SUPPL2019-01-09
45292SUPPL2016-09-12
45264SUPPL2016-09-09
10481SUPPL2016-05-02
19669SUPPL2016-04-29
44928ORIG2016-03-02
22997ORIG2016-03-02
40487ORIG2015-04-28
32695ORIG2015-04-03
32696ORIG2015-03-10
51482SUPPL1900-01-01
51481SUPPL1900-01-01
51468SUPPL1900-01-01
51461ORIG1900-01-01
51459ORIG1900-01-01
51457ORIG1900-01-01