FDA.report

Application 020503

Type
NDA
Sponsor
3M DRUG DELIVERY

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PROVENTIL-HFAALBUTEROL SULFATEAEROSOL, METERED;INHALATIONEQ 0.09MG BASE/INHYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0085-1132Proventil HFAAlbuterol SulfateMerck Sharp & Dohme Corp.NDACurrent
0085-1132Proventil HFAAlbuterol SulfateMerck Sharp & Dohme Corp.NDACurrent
0085-1132Proventil HFAAlbuterol SulfateMerck Sharp & Dohme Corp.NDACurrent
0085-1132Proventil HFAAlbuterol SulfateMerck Sharp & Dohme Corp.NDACurrent
0085-1132Proventil HFAAlbuterol SulfateMerck Sharp & Dohme Corp.NDACurrent
0085-1132Proventil HFAAlbuterol SulfateMerck Sharp & Dohme Corp.NDACurrent
0254-1007Albuterol SulfateAlbuterol SulfatePar PharmaceuticalsNDA AUTHORIZED GENERICCurrent
0254-1007Albuterol SulfateAlbuterol SulfatePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
0254-1007Albuterol SulfateAlbuterol SulfatePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
0254-1007Albuterol SulfateAlbuterol SulfatePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
0254-1007Albuterol SulfateAlbuterol SulfatePar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
0781-7296Albuterol SulfateAlbuterol SulfateSandoz IncNDA AUTHORIZED GENERICCurrent
0781-7296Albuterol SulfateAlbuterol SulfateSandoz IncNDA AUTHORIZED GENERICCurrent
42254-004Proventil HFAAlbuterol SulfateRebel Distributors Corp.NDACurrent
50090-0624Proventil HFAAlbuterol SulfateA-S Medication SolutionsNDACurrent
50090-4326Proventil HFAAlbuterol SulfateA-S Medication SolutionsNDACurrent
55700-908Albuterol SulfateAlbuterol SulfateQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
55700-908Albuterol SulfateAlbuterol SulfateQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
63629-8468Albuterol SulfateAlbuterol SulfateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-8468Albuterol SulfateAlbuterol SulfateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
66758-959Proventil HFAAlbuterol SulfateSandozNDACurrent
66758-959Proventil HFAAlbuterol SulfateSandozNDACurrent
66758-959Proventil HFAAlbuterol SulfateSandozNDACurrent
66758-959Proventil HFAAlbuterol SulfateSandozNDACurrent
68071-2367Albuterol SulfateAlbuterol SulfateNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68071-2505Albuterol SulfateAlbuterol SulfateNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68788-7881Albuterol SulfateAlbuterol SulfatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7996Albuterol SulfateAlbuterol SulfatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
68788-7996Albuterol SulfateAlbuterol SulfatePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent

Documents

DocumentSubmission typeDate
49856SUPPL2017-09-26
49854SUPPL2017-09-25
41399SUPPL2015-03-10
34720SUPPL2012-06-11
2611SUPPL2012-06-07
2610SUPPL2009-11-12
34719SUPPL2009-09-17
25057SUPPL2004-02-03
41398SUPPL1999-06-02
2609SUPPL1999-06-02
34718SUPPL1998-09-23
25056SUPPL1998-09-23
20685SUPPL1998-09-23