FDA.reportPublic FDA data

Application 021457

Type
NDA
Sponsor
TEVA BRANDED PHARM

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3174Albuterol SulfateAlbuterol SulfateTeva Pharmaceuticals USA, Inc.NDACurrent
0093-3174Albuterol SulfateAlbuterol SulfateTeva Pharmaceuticals USA, Inc.NDACurrent
0093-3174Albuterol SulfateAlbuterol SulfateTeva Pharmaceuticals USA, Inc.NDACurrent
0093-3174Albuterol SulfateAlbuterol SulfateTeva Pharmaceuticals USA, Inc.NDACurrent
0093-3174Albuterol SulfateAlbuterol SulfateTeva Pharmaceuticals USA, Inc.NDACurrent
0093-3174Albuterol SulfateAlbuterol SulfateTeva Pharmaceuticals USA, Inc.NDACurrent
21695-851PROAIRalbuterol sulfateRebel Distributors CorpNDACurrent
49999-908PROAIRalbuterol sulfateLake Erie Medical & Surgical Supply DBA Quality Care Products LLCNDACurrent
49999-908PROAIRalbuterol sulfateLake Erie Medical & Surgical Supply DBA Quality Care Products LLCNDACurrent
50090-1329PROAIRAlbuterol SulfateA-S Medication SolutionsNDACurrent
50090-1329PROAIRAlbuterol SulfateA-S Medication SolutionsNDACurrent
50090-1329PROAIRAlbuterol SulfateA-S Medication SolutionsNDACurrent
50090-4138Albuterol SulfateAlbuterol SulfateA-S Medication SolutionsNDACurrent
50090-4138Albuterol SulfateAlbuterol SulfateA-S Medication SolutionsNDACurrent
50090-4138Albuterol SulfateAlbuterol SulfateA-S Medication SolutionsNDACurrent
50090-4491PROAIRAlbuterol SulfateA-S Medication SolutionsNDACurrent
50090-4491PROAIRAlbuterol SulfateA-S Medication SolutionsNDACurrent
51662-1202ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1202ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1202ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52959-978PROAIRHFAalbuterol sulfateH.J. Harkins Company, Inc.NDACurrent
53002-1550PROAIRAlbuterol SulfateRPK Pharmaceuticals, Inc.NDACurrent
53002-1550PROAIRAlbuterol SulfateRPK Pharmaceuticals, Inc.NDACurrent
53002-1551Albuterol SulfateAlbuterol SulfateRPK Pharmaceuticals, Inc.NDACurrent
59310-579PROAIRAlbuterol SulfateTeva Respiratory, LLCNDACurrent
59310-579PROAIRAlbuterol SulfateTeva Respiratory, LLCNDACurrent
59310-579PROAIRAlbuterol SulfateTeva Respiratory, LLCNDACurrent
59310-579PROAIRAlbuterol SulfateTeva Respiratory, LLCNDACurrent
63187-540PROAIRalbuterol sulfateProficient Rx LPNDACurrent
63187-540PROAIRalbuterol sulfateProficient Rx LPNDACurrent
64725-5790PROAIRalbuterol sulfateTYA PharmaceuticalsNDACurrent
68071-1525PROAIRAlbuterol SulfateNuCare Pharmaceuticals,Inc.NDACurrent
68071-1525PROAIRAlbuterol SulfateNuCare Pharmaceuticals,Inc.NDACurrent
68071-1525PROAIRAlbuterol SulfateNuCare Pharmaceuticals,Inc.NDACurrent
68071-4940Albuterol SulfateAlbuterol SulfateNuCare Pharmaceuticals,Inc.NDACurrent
68071-4940Albuterol SulfateAlbuterol SulfateNuCare Pharmaceuticals,Inc.NDACurrent
68071-4940Albuterol SulfateAlbuterol SulfateNuCare Pharmaceuticals,Inc.NDACurrent
68788-7477Albuterol SulfateAlbuterol SulfatePreferred Relabeled By: Preferred Pharmaceuticals Inc.NDACurrent
68788-7477Albuterol SulfateAlbuterol SulfatePreferred Relabeled By: Preferred Pharmaceuticals Inc.NDACurrent
68788-9900PROAIRalbuterol sulfatePreferred Pharmaceuticals, IncNDACurrent
68788-9900PROAIRalbuterol sulfatePreferred Pharmaceuticals, IncNDACurrent
68788-9900PROAIRalbuterol sulfatePreferred Pharmaceuticals, IncNDACurrent
70518-1230PROAIRAlbuterol SulfateREMEDYREPACK INC.NDACurrent
70518-1230PROAIRAlbuterol SulfateREMEDYREPACK INC.NDACurrent
70518-1230PROAIRAlbuterol SulfateREMEDYREPACK INC.NDACurrent
70518-1230PROAIRAlbuterol SulfateREMEDYREPACK INC.NDACurrent
71205-211Albuterol SulfateAlbuterol SulfateProficient Rx LPNDACurrent
71205-211Albuterol SulfateAlbuterol SulfateProficient Rx LPNDACurrent
71205-211Albuterol SulfateAlbuterol SulfateProficient Rx LPNDACurrent
71205-211Albuterol SulfateAlbuterol SulfateProficient Rx LPNDACurrent
76420-088Albuterol SulfateAlbuterol SulfateAsclemed USA, Inc.NDACurrent
76420-088Albuterol SulfateAlbuterol SulfateAsclemed USA, Inc.NDACurrent
76519-1171ALBUTEROL SULFATEALBUTEROL SULFATEH.J. Harkins Company, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57812SUPPL2019-02-26
57810SUPPL2019-02-26
15525SUPPL2012-11-29
27849SUPPL2010-12-15
5446SUPPL2010-08-20
15524SUPPL2010-08-19
36990SUPPL2008-09-19
27848SUPPL2008-09-17
21672ORIG2007-04-30
36988SUPPL2007-01-17
23958SUPPL2006-02-08
36989SUPPL2005-11-30
36987SUPPL2005-11-30
27847SUPPL2005-11-30
5445SUPPL2005-11-30
36986SUPPL2005-05-04
5444SUPPL2005-05-04
36985ORIG2004-11-08
5443ORIG2004-11-08