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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205636-001PROAIR RESPICLICKALBUTEROL SULFATEEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31
N205636-002PROAIR DIGIHALERALBUTEROL SULFATEEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-3184e616aacf4f…
2026-09-14 22:38:342026-08N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-2184e616aacf4f…
2026-08-18 06:07:402026-07N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205636-001PROAIR RESPICLICKEQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD, RS2015-03-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N205636-002PROAIR DIGIHALEREQ 0.09MG BASE/INHPOWDER, METERED / INHALATIONRLD2018-12-2174a2ff9319b5…

Observed Orange Book patent history#

Patent history page 1 of 29 · 1,149 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-08-23 18:47 UTC2025-08N205636-001107658202025-05-19Drug product2020-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00194632882025-05-19Drug product2016-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00186511032028-03-26Drug product2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-001100225102031-05-18Drug product2018-08-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-001101241312031-05-18Drug product2018-12-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00197310872031-05-18Drug product2017-08-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00192162602031-06-28Drug product2016-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00189789662032-01-13Drug product2016-01-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002107658202025-05-19Drug product2020-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00294632882025-05-19Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00286511032028-03-26Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002100225102031-05-18Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002101241312031-05-18Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00297310872031-05-18Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00292162602031-06-28Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00289789662032-01-13Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00297825502035-08-28Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-00297825512035-08-28Drug product2019-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002109188162035-12-14Drug product2021-03-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002105690342036-08-16Drug product2020-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002113513172038-02-10Drug product2022-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002113579352038-09-24Drug product2022-07-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002110006532038-12-18Drug product2021-06-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002113446852039-09-26Drug product2022-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002114397772040-05-24Drug product2022-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002114649232040-06-19Drug product2022-11-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002111732592040-07-06Drug product2021-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N205636-002112667962041-02-22Drug product2022-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-001107658202025-05-19Drug product2020-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00194632882025-05-19Drug product2016-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00186511032028-03-26Drug product2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-001100225102031-05-18Drug product2018-08-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-001101241312031-05-18Drug product2018-12-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00197310872031-05-18Drug product2017-08-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00192162602031-06-28Drug product2016-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-001105618082032-01-01Drug product2020-03-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00189789662032-01-13Drug product2016-01-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-002107658202025-05-19Drug product2020-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00294632882025-05-19Drug product2019-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205636-00286511032028-03-26Drug product2019-01-09fd3edfee7708…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N205636-001NPP2019-04-2874a2ff9319b5…
2019-12-14 00:12 UTC2019-12N205636-001NPP2019-04-283f01610625f2…
2019-09-15 20:21 UTC2019-09N205636-001NPP2019-04-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N205636-001NPP2019-04-28ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Albuterol SulfateALBUTEROL SULFATEProficient Rx LP07b1ee8b-d920-49dd-9fad-cb0fe8a35e0d2023-10-01Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol Sulfate HFAALBUTEROL SULFATEProficient Rx LPd617e361-5c03-45ac-9bbe-0fa418edb19f2023-10-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
VENTOLIN HFAALBUTEROL SULFATEProficient Rx LP6dc143e7-6bab-42c8-b3e9-9d604d202e732023-10-01Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATEALBUTEROL SULFATEA-S Medication Solutionsa9188951-3711-412c-89c6-e8db784dcb652023-09-20Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEA-S Medication Solutions8f52f15f-3fb7-4b00-a19f-8721c5ac55db2023-07-24Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEChartwell RX, LLC81cdae6f-99d7-468b-9ab8-fecb1d42298d2023-06-19Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEMedical Purchasing Solutions, LLC6a4b4b95-d1d3-9051-e053-2a91aa0a52e82023-05-30Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
albuterol sulfate HFAALBUTEROL SULFATEA-S Medication Solutions4378c5b0-529f-44b4-bdf1-e9f2631df8cd2023-02-06Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEHikma Pharmaceuticals USA Inc.6c64ab5d-f8a2-440a-a929-cb8188d0e8b42023-01-01Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol sulfateALBUTEROL SULFATEProficient Rx LP4100bce5-096c-42e4-9e4e-d11a0ab597d52023-01-01Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEAsclemed USA, Inc.87ff8be7-3a49-44bd-92de-eb8db24af95b2022-12-13Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirstad299502-8779-d280-e053-2995a90a73712022-12-10Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
albuterol sulfateALBUTEROL SULFATEProficient Rx LP918551c7-c3c1-43bc-b575-b33fdb4e96fc2022-12-01Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEProficient Rx LPd3d2ab1e-8f91-4a4d-aa6b-5a57f59ad56b2022-11-01Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
ALBUTEROL SULFATEALBUTEROL SULFATEExelan Pharmaceuticals, Inc.29e35e54-dbd6-4426-993f-893d7a4d69be2022-02-10Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE
Albuterol SulfateALBUTEROL SULFATEAsclemed USA, Inc.8153d82c-b5c5-4aa2-bce5-b69cf2d23f5d2020-10-16Warnings, Adverse reactionsName fallback
generic name: ALBUTEROL SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

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