Application 207921

Type
NDA
Sponsor
NORTON WATERFORD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QVAR REDIHALERBECLOMETHASONE DIPROPIONATEAEROSOL, METERED;INHALATION0.04MG/INHYesNo
002QVAR REDIHALERBECLOMETHASONE DIPROPIONATEAEROSOL, METERED;INHALATION0.08MG/INHYesNo

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

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
N207921-001QVAR REDIHALERBECLOMETHASONE DIPROPIONATE0.04MG/INHAEROSOL, METERED / INHALATIONRLD, RS2017-08-03
N207921-002QVAR REDIHALERBECLOMETHASONE DIPROPIONATE0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2017-08-03

Orange Book patents#

Current patent rows page 1 of 1 · 32 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N207921-00181327122028-09-07Drug product, Delist requested2017-08-28
N207921-001100225092031-05-18Drug product, Delist requested2018-08-13
N207921-001100225102031-05-18Drug product, Delist requested2018-08-13
N207921-001100861562031-05-18Drug product, Delist requested2018-10-16
N207921-001106955122031-05-18Drug product, Delist requested2020-07-28
N207921-001113958892031-05-18Drug product, Delist requested2022-08-19
N207921-00189314762031-07-17Drug product2017-08-28
N207921-001105618082032-01-01Drug product, Delist requested2020-03-19
N207921-001113958882038-01-26Drug product2022-08-19
N207921-001117939532038-01-26Drug product2023-11-13
N207921-001122960892038-01-26Drug product2025-06-02
N207921-001107924472039-01-25Drug product2020-10-29
N207921-001115596372039-07-21Drug product2023-02-22
N207921-001119578322041-05-05Drug product2024-05-07
N207921-001115836432041-08-19Drug product2023-03-20
N207921-00281327122028-09-07Drug product, Delist requested2017-08-28
N207921-002100225092031-05-18Drug product, Delist requested2018-08-13
N207921-002100225102031-05-18Drug product, Delist requested2018-08-13
N207921-002100861562031-05-18Drug product, Delist requested2018-10-16
N207921-002106955122031-05-18Drug product, Delist requested2020-07-28
N207921-002113958892031-05-18Drug product, Delist requested2022-08-19
N207921-00289314762031-07-17Drug product2017-08-28
N207921-002105618082032-01-01Drug product, Delist requested2020-03-19
N207921-002113958882038-01-26Drug product2022-08-19
N207921-002117939532038-01-26Drug product2023-11-13
N207921-002118652472038-01-26Drug product, Delist requested2024-01-23
N207921-002118967592038-01-26Drug product, Delist requested2024-03-11
N207921-002122960892038-01-26Drug product2025-06-02
N207921-002107924472039-01-25Drug product2020-10-29
N207921-002115596372039-07-21Drug product2023-02-22
N207921-002119578322041-05-05Drug product2024-05-07
N207921-002115836432041-08-19Drug product2023-03-20

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD, RS2017-08-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD, RS2017-08-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03d06236e962d9…
2024-10-29 15:01 UTC2024-10N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N207921-001QVAR REDIHALER0.04MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03782e0a99824c…
2021-12-28 21:50 UTC2021-12N207921-002QVAR REDIHALER0.08MG/INHAEROSOL, METERED / INHALATIONRLD2017-08-03782e0a99824c…

Observed Orange Book patent history#

Patent history page 1 of 25 · 972 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N207921-00181327122028-09-07Drug product, Delist requested2017-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-001100225092031-05-18Drug product, Delist requested2018-08-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-001100225102031-05-18Drug product, Delist requested2018-08-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-001100861562031-05-18Drug product, Delist requested2018-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-001106955122031-05-18Drug product, Delist requested2020-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-001113958892031-05-18Drug product, Delist requested2022-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-00189314762031-07-17Drug product2017-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-001105618082032-01-01Drug product, Delist requested2020-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-001113958882038-01-26Drug product2022-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-001117939532038-01-26Drug product2023-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-001122960892038-01-26Drug product2025-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-001107924472039-01-25Drug product2020-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-001115596372039-07-21Drug product2023-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-001119578322041-05-05Drug product2024-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-001115836432041-08-19Drug product2023-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-00281327122028-09-07Drug product, Delist requested2017-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002100225092031-05-18Drug product, Delist requested2018-08-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002100225102031-05-18Drug product, Delist requested2018-08-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002100861562031-05-18Drug product, Delist requested2018-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002106955122031-05-18Drug product, Delist requested2020-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002113958892031-05-18Drug product, Delist requested2022-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-00289314762031-07-17Drug product2017-08-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002105618082032-01-01Drug product, Delist requested2020-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002113958882038-01-26Drug product2022-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002117939532038-01-26Drug product2023-11-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002118652472038-01-26Drug product, Delist requested2024-01-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002118967592038-01-26Drug product, Delist requested2024-03-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002122960892038-01-26Drug product2025-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002107924472039-01-25Drug product2020-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002115596372039-07-21Drug product2023-02-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002119578322041-05-05Drug product2024-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207921-002115836432041-08-19Drug product2023-03-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207921-00181327122028-09-07Drug product, Delist requested2017-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207921-001100225092031-05-18Drug product, Delist requested2018-08-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207921-001100225102031-05-18Drug product, Delist requested2018-08-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207921-001100861562031-05-18Drug product, Delist requested2018-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207921-001106955122031-05-18Drug product, Delist requested2020-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207921-001113958892031-05-18Drug product, Delist requested2022-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207921-00189314762031-07-17Drug product2017-08-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207921-001105618082032-01-01Drug product, Delist requested2020-03-1931067a03dcf5…

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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QVAR REDIHALERBECLOMETHASONE DIPROPIONATE HFATeva Respiratory, LLCcada897a-264e-450d-ae00-36e7fe7470802025-09-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 207921
application number: NDA207921
ndc (product): 59310-304
ndc (product): 59310-302
QVAR REDIHALERBECLOMETHASONE DIPROPIONATE HFAA-S Medication Solutionsccd3aaec-4892-40d0-ad60-3e570178fbe12024-06-25Warnings, Adverse reactionsExact identifier
application applno (NDA): 207921
application number: NDA207921
ndc (product): 50090-3459
QVAR REDIHALERBECLOMETHASONE DIPROPIONATE HFAA-S Medication Solutions6c19254b-6333-46fa-835b-16b48df57bdd2023-09-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 207921
application number: NDA207921
ndc (product): 50090-5031
QVAR REDIHALERBECLOMETHASONE DIPROPIONATE HFAA-S Medication Solutions2814cf81-392e-4dd4-9816-ae7e6e5ec84f2023-09-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 207921
application number: NDA207921
ndc (product): 50090-5032

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3459QVAR REDIHALERBeclomethasone Dipropionate HFAA-S Medication SolutionsNDACurrent
50090-5031QVAR REDIHALERBeclomethasone Dipropionate HFAA-S Medication SolutionsNDACurrent
50090-5031QVAR REDIHALERBeclomethasone Dipropionate HFAA-S Medication SolutionsNDACurrent
50090-5032QVAR REDIHALERBeclomethasone Dipropionate HFAA-S Medication SolutionsNDACurrent
50090-5032QVAR REDIHALERBeclomethasone Dipropionate HFAA-S Medication SolutionsNDACurrent
53002-2436QVAR REDIHALERBeclomethasone Dipropionate HFARPK Pharmaceuticals, Inc.NDACurrent
53002-2436QVAR REDIHALERBeclomethasone Dipropionate HFARPK Pharmaceuticals, Inc.NDACurrent
53002-3477QVAR REDIHALERBeclomethasone Dipropionate HFARPK Pharmaceuticals, Inc.NDACurrent
53002-3477QVAR REDIHALERBeclomethasone Dipropionate HFARPK Pharmaceuticals, Inc.NDACurrent
59310-302QVAR REDIHALERBeclomethasone Dipropionate HFATeva Respiratory, LLCNDACurrent
59310-302QVAR REDIHALERBeclomethasone Dipropionate HFATeva Respiratory, LLCNDACurrent
59310-302QVAR REDIHALERBeclomethasone Dipropionate HFATeva Respiratory, LLCNDACurrent
59310-302QVAR REDIHALERBeclomethasone Dipropionate HFATeva Respiratory, LLCNDACurrent
59310-302QVAR REDIHALERBeclomethasone Dipropionate HFATeva Respiratory, LLCNDACurrent
59310-302QVAR REDIHALERBeclomethasone Dipropionate HFATeva Respiratory, LLCNDACurrent
59310-304QVAR REDIHALERBeclomethasone Dipropionate HFATeva Respiratory, LLCNDACurrent
59310-304QVAR REDIHALERBeclomethasone Dipropionate HFATeva Respiratory, LLCNDACurrent
59310-304QVAR REDIHALERBeclomethasone Dipropionate HFATeva Respiratory, LLCNDACurrent
59310-304QVAR REDIHALERBeclomethasone Dipropionate HFATeva Respiratory, LLCNDACurrent
59310-304QVAR REDIHALERBeclomethasone Dipropionate HFATeva Respiratory, LLCNDACurrent
59310-304QVAR REDIHALERBeclomethasone Dipropionate HFATeva Respiratory, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83595SUPPL 2025-09-30
83569SUPPL 2025-09-29
77607SUPPL 2024-02-23
77604SUPPL 2024-02-23
65875SUPPL2021-01-08
65864SUPPL2021-01-07
52667ORIG2018-02-16
49256ORIG2017-08-07
49250ORIG2017-08-04