Application 208437

Type
NDA
Sponsor
SUNOVION RESP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LONHALA MAGNAIR KITGLYCOPYRROLATESOLUTION;INHALATION25MCG/MLYesYes

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
N208437-001LONHALA MAGNAIR KITGLYCOPYRROLATE25MCG/MLSOLUTION / INHALATIONRLD2017-12-05

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208437-001112786832026-08-16Drug product2022-03-25
N208437-00192659002028-12-07Drug product2018-01-02
N208437-001109401102029-02-26U-1773Drug product2021-03-16
N208437-00197892702030-10-30Drug product2018-01-02
N208437-00191685562032-09-01Drug product2018-01-02
N208437-00196040182033-05-16Drug product2018-01-02
N208437-001103766612035-09-14Drug product2019-09-05
N208437-001106885182036-11-12Drug product2020-06-30
N208437-001107442772036-12-07U-2941Drug product2020-09-01

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-0587673890dc5c…
2021-03-12 10:30 UTC2021-03N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-053f01610625f2…
2019-09-15 20:21 UTC2019-09N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-05b00525d2431f…
2019-07-19 19:46 UTC2019-07N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD2017-12-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-053f0d92c62455…
2023-05-13 08:27 UTC2023-05N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-05053a50430f4f…
2023-01-26 05:58 UTC2023-01N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208437-001LONHALA MAGNAIR KIT25MCG/MLSOLUTION / INHALATIONRLD, RS2017-12-05cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 12 · 464 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208437-001112786832026-08-16Drug product2022-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208437-00192659002028-12-07Drug product2018-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208437-001109401102029-02-26U-1773Drug product2021-03-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208437-00197892702030-10-30Drug product2018-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208437-00191685562032-09-01Drug product2018-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208437-00196040182033-05-16Drug product2018-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208437-001103766612035-09-14Drug product2019-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208437-001106885182036-11-12Drug product2020-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208437-001107442772036-12-07U-2941Drug product2020-09-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208437-00179312122025-11-25Drug product2018-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208437-001112786832026-08-16Drug product2022-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208437-00192659002028-12-07Drug product2018-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208437-001109401102029-02-26U-1773Drug product2021-03-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208437-00197892702030-10-30Drug product2018-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208437-00191685562032-09-01Drug product2018-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208437-00196040182033-05-16Drug product2018-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208437-001103766612035-09-14Drug product2019-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208437-001106885182036-11-12Drug product2020-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208437-001107442772036-12-07U-2941Drug product2020-09-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N208437-00179312122025-11-25Drug product2018-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208437-001112786832026-08-16Drug product2022-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208437-00192659002028-12-07Drug product2018-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208437-001109401102029-02-26U-1773Drug product2021-03-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208437-00197892702030-10-30Drug product2018-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208437-00191685562032-09-01Drug product2018-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208437-00196040182033-05-16Drug product2018-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208437-001103766612035-09-14Drug product2019-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208437-001106885182036-11-12Drug product2020-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208437-001107442772036-12-07U-2941Drug product2020-09-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208437-00179312122025-11-25Drug product2018-01-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208437-001112786832026-08-16Drug product2022-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208437-00192659002028-12-07Drug product2018-01-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208437-001109401102029-02-26U-1773Drug product2021-03-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208437-00197892702030-10-30Drug product2018-01-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208437-00191685562032-09-01Drug product2018-01-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208437-00196040182033-05-16Drug product2018-01-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208437-001103766612035-09-14Drug product2019-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208437-001106885182036-11-12Drug product2020-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208437-001107442772036-12-07U-2941Drug product2020-09-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208437-00179312122025-11-25Drug product2018-01-02b8a1b40f171c…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N208437-001NP2020-12-0574a2ff9319b5…
2020-12-22 03:56 UTC2020-12N208437-001NP2020-12-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208437-001NP2020-12-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208437-001NP2020-12-053f01610625f2…
2019-09-15 20:21 UTC2019-09N208437-001NP2020-12-05b00525d2431f…
2019-07-19 19:46 UTC2019-07N208437-001NP2020-12-05ea99ee380514…

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 6 · 116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEPar Health USA, LLC1f266d77-4f9e-44c9-a000-2f8fea3ac80b2026-07-09Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEPiramal Critical Care Inc83d70378-011b-4ce3-e053-2991aa0a22be2026-06-23Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATECardinal Health 107, LLC65688bed-0d70-4b51-8301-1948b1deade12026-06-02Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEREMEDYREPACK INC.220cd5f5-3d71-4fdb-9943-7468799c179f2026-06-02Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEGolden State Medical Supply, Inc.ec15e70c-8473-469a-9f07-ea668783fa072026-05-27Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEMeitheal Pharmaceuticals Inc.02541cfd-b209-49b9-a73f-13ef18dce06d2026-05-20Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEPar Health USA, LLCff65c5d3-7ba9-4315-a884-199151eb45a52026-05-14Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack098c7654-a352-47ee-bf23-6a81f86012662026-05-05Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEAtlantic Biologicals Corp.50b493d7-8e3b-e459-e063-6394a90addbc2026-04-30Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEGland Pharma Limitedd670bd26-8a44-44be-90e1-107d4c3802332026-04-28Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
glycopyrrolateGLYCOPYRROLATEAmneal Pharmaceuticals LLC741355f5-b695-41bb-a065-4abc687312b22026-04-28Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATESagent Pharmaceuticals55930f87-8964-43b1-b790-c1e6dd2602d22026-04-20Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack21c7d201-c0b8-4f16-be4a-681d0b22791e2026-04-03Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATESandoz Inccb1ae370-ec4f-4114-9860-8f736f72b5452026-04-01Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEREMEDYREPACK INC.a338ef22-c243-4075-b02d-bcd5b590104a2026-03-26Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEREMEDYREPACK INC.fafea739-87d0-4421-833f-eb066791504c2026-03-26Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATELifestar Pharma LLC0f4a4b94-71e0-49ed-8f1e-c760e4dd31372026-03-25Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GlycopyrrolateGLYCOPYRROLATEMajor Pharmaceuticals6e5bfe6d-d321-4f0f-86e2-457d8fd10a6a2026-03-19Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
glycopyrrolateGLYCOPYRROLATEBionpharma Inc.512d3f1e-c35c-87c2-e063-6394a90a8de02026-03-05Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE
GLYCOPYRROLATEGLYCOPYRROLATENCS HealthCare of KY, LLC dba Vangard Labs5ed930b7-a36e-4bf8-b1d1-dad238d3dd182026-02-25Warnings, Adverse reactionsName fallback
generic name: GLYCOPYRROLATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60940-024LonhalaGlycopyrrolateHolopack Verpackungstechnik GmbHNDACurrent
60940-024LonhalaGlycopyrrolateHolopack Verpackungstechnik GmbHNDACurrent
60940-024LonhalaGlycopyrrolateHolopack Verpackungstechnik GmbHNDACurrent
60940-024LonhalaGlycopyrrolateHolopack Verpackungstechnik GmbHNDACurrent
63402-201LONHALA MAGNAIRglycopyrrolateSunovion Pharmaceuticals Inc.NDACurrent
63402-201LONHALA MAGNAIRglycopyrrolateSunovion Pharmaceuticals Inc.NDACurrent
63402-201LONHALA MAGNAIRglycopyrrolateSunovion Pharmaceuticals Inc.NDACurrent
63402-301LONHALA MAGNAIRglycopyrrolateSunovion Pharmaceuticals Inc.NDACurrent
63402-301LONHALA MAGNAIRglycopyrrolateSunovion Pharmaceuticals Inc.NDACurrent
63402-301LONHALA MAGNAIRglycopyrrolateSunovion Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59179SUPPL2019-06-27
59167SUPPL2019-06-25
56560ORIG2018-11-26
56096ORIG2018-10-26
50621ORIG2017-12-06