FDA.reportPublic FDA data

Application 020983

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VENTOLIN HFAALBUTEROL SULFATEAEROSOL, METERED;INHALATIONEQ 0.09MG BASE/INHYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0682VENTOLINalbuterol sulfateGlaxoSmithKline LLCNDACurrent
0173-0682VENTOLINalbuterol sulfateGlaxoSmithKline LLCNDACurrent
0173-0682VENTOLINalbuterol sulfateGlaxoSmithKline LLCNDACurrent
0173-0682VENTOLINalbuterol sulfateGlaxoSmithKline LLCNDACurrent
0173-0682VENTOLINalbuterol sulfateGlaxoSmithKline LLCNDACurrent
0173-0682VENTOLINalbuterol sulfateGlaxoSmithKline LLCNDACurrent
0173-0682VENTOLINalbuterol sulfateGlaxoSmithKline LLCNDACurrent
21695-423VENTOLINHFAalbuterol sulfateRebel Distributors Corp.NDACurrent
35356-166VENTOLINalbuterol sulfateLake Erie Medical DBA QuaNDACurrent
35356-166VENTOLINalbuterol sulfateLake Erie Medical DBA Quality Care Products LLCNDACurrent
50090-1158VENTOLINalbuterol sulfateA-S Medication SolutionsNDACurrent
50090-1159VENTOLINalbuterol sulfateA-S Medication SolutionsNDACurrent
50090-1159VENTOLINalbuterol sulfateA-S Medication SolutionsNDACurrent
50090-1159VENTOLINalbuterol sulfateA-S Medication SolutionsNDACurrent
50090-4137albuterol sulfate HFAalbuterol sulfateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4137albuterol sulfate HFAalbuterol sulfateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4137albuterol sulfate HFAalbuterol sulfateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4137albuterol sulfate HFAalbuterol sulfateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4143Albuterol Sulfatealbuterol sulfateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4143Albuterol Sulfatealbuterol sulfateA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50436-0682VENTOLINalbuterol sulfateUnit Dose ServicesNDACurrent
50436-6050VENTOLINalbuterol sulfateUnit Dose ServicesNDACurrent
51662-1267ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1267ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1267ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1267ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52959-983VENTOLINalbuterol sulfateH.J. Harkins Company, Inc.NDACurrent
53002-1584VENTOLINalbuterol sulfateRPK Pharmaceuticals, Inc.NDACurrent
53002-1584VENTOLINalbuterol sulfateRPK Pharmaceuticals, Inc.NDACurrent
53002-2584Albuterol Sulfatealbuterol sulfateRPK Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
63187-026VENTOLINalbuterol sulfateProficient Rx LPNDACurrent
63187-026VENTOLINalbuterol sulfateProficient Rx LPNDACurrent
63187-026VENTOLINalbuterol sulfateProficient Rx LPNDACurrent
63187-026VENTOLINalbuterol sulfateProficient Rx LPNDACurrent
66993-019Albuterol Sulfatealbuterol sulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-019Albuterol Sulfatealbuterol sulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-019Albuterol Sulatealbuterol sulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-019Albuterol Sulfatealbuterol sulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-019Albuterol Sulfatealbuterol sulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-019Albuterol Sulfatealbuterol sulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-019Albuterol Sulfatealbuterol sulfatePrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
68071-1670VENTOLINalbuterol sulfateNuCare Pharmaceuticals,Inc.NDACurrent
68071-1670VENTOLINalbuterol sulfateNuCare Pharmaceuticals,Inc.NDACurrent
68071-1670VENTOLINalbuterol sulfateNuCare Pharmaceuticals,Inc.NDACurrent
68071-1890VENTOLINalbuterol sulfateNuCare Pharmaceuticals,Inc.NDACurrent
68071-1890VENTOLINalbuterol sulfateNuCare Pharmaceuticals,Inc.NDACurrent
68071-1890VENTOLINalbuterol sulfateNuCare Pharmaceuticals,Inc.NDACurrent
68071-1890VENTOLINalbuterol sulfateNuCare Pharmaceuticals,Inc.NDACurrent
68071-4777Albuterol Sulatealbuterol sulfateNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-4777Albuterol Sulatealbuterol sulfateNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-4777Albuterol Sulatealbuterol sulfateNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68258-3037VENTOLINalbuterol sulfateDispensing Solutions Inc.NDACurrent
68788-7229VENTOLINalbuterol sulfatePreferred Pharmaceuticals Inc.NDACurrent
68788-7229VENTOLINalbuterol sulfatePreferred Pharmaceuticals Inc.NDACurrent
68788-7353Albuterol Sulatealbuterol sulfatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7353Albuterol Sulatealbuterol sulfatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7353Albuterol Sulatealbuterol sulfatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7353Albuterol Sulatealbuterol sulfatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-9552VENTOLINalbuterol sulfatePreferred Pharmaceuticals, Inc.NDACurrent
68788-9552VENTOLINalbuterol sulfatePreferred Pharmaceuticals, Inc.NDACurrent
70518-1081VENTOLINalbuterol sulfateREMEDYREPACK INC.NDACurrent
70518-1081VENTOLINalbuterol sulfateREMEDYREPACK INC.NDACurrent
70518-1081VENTOLINalbuterol sulfateREMEDYREPACK INC.NDACurrent
70518-1081VENTOLINalbuterol sulfateREMEDYREPACK INC.NDACurrent
70518-1237VENTOLINalbuterol sulfateREMEDYREPACK INC.NDACurrent
70518-1237VENTOLINalbuterol sulfateREMEDYREPACK INC.NDACurrent
70518-1237VENTOLINalbuterol sulfateREMEDYREPACK INC.NDACurrent
70518-1237VENTOLINalbuterol sulfateREMEDYREPACK INC.NDACurrent
70518-1237VENTOLINalbuterol sulfateREMEDYREPACK INC.NDACurrent
70518-1237VENTOLINalbuterol sulfateREMEDYREPACK INC.NDACurrent
70518-1237VENTOLINalbuterol sulfateREMEDYREPACK INC.NDACurrent
70518-2072Albuterol Sulatealbuterol sulfateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
70518-2072Albuterol Sulatealbuterol sulfateREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent
72189-016VENTOLIN HFAalbuterol sulfateDIRECT RXNDACurrent
76519-1175ALBUTEROL SULFATEALBUTEROL SULFATEH.J. Harkins Company, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68421SUPPL2021-08-19
68413SUPPL2021-08-19
61340SUPPL2019-12-19
61322SUPPL2019-12-17
14083SUPPL2015-01-09
3934SUPPL2014-12-23
35786SUPPL2012-09-11
3933SUPPL2012-09-07
41860SUPPL2012-02-14
51192SUPPL2008-08-27
51189SUPPL2008-08-27
51185SUPPL2008-08-27
51157SUPPL2008-08-27
51155SUPPL2008-08-27
26373SUPPL2008-04-02
14082SUPPL2008-03-27
35785SUPPL2005-04-28
3932SUPPL2005-04-28
35784ORIG2001-04-19
21326ORIG2001-04-19
3931ORIG2001-04-19
53162SUPPL1900-01-01
53161SUPPL1900-01-01
53160SUPPL1900-01-01