FDA.reportPublic FDA data

Application 020503

Type
NDA
Sponsor
3M DRUG DELIVERY

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020503-001PROVENTIL-HFAALBUTEROL SULFATEEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020503-001AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020503-001PROVENTIL-HFAEQ 0.09MG BASE/INHAEROSOL, METERED / INHALATIONAB1RLD, RS1996-08-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020503-001AB11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Albuterol SulfateALBUTEROL SULFATEPreferred Pharmaceuticals Inc.d6acb5a7-555a-463a-ae65-2911d6789b422026-01-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 020503
application number: NDA020503
ndc (product): 68788-7996
Albuterol SulfateALBUTEROL SULFATESandoz Incf8a2c4b7-a162-48ab-90b0-350e4da25c662025-12-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 020503
application number: NDA020503
ndc (product): 0781-7296
Albuterol SulfateALBUTEROL SULFATEREMEDYREPACK INC.32dbec5e-044a-40b6-9b88-e1396c4b4b6e2025-12-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 020503
application number: NDA020503
Albuterol SulfateALBUTEROL SULFATEProficient Rx LP07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d2023-10-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 020503
application number: NDA020503

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
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#

Document, Submission type, Date table
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