FDA.reportPublic FDA data

Application 207930

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UTIBRONGLYCOPYRROLATE; INDACATEROL MALEATEPOWDER;INHALATION15.6MCG/INH;27.5MCG/INHYesNo

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
N207930-001UTIBRON NEOHALERGLYCOPYRROLATE; INDACATEROL MALEATE15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N207930-00184797302028-10-11Drug product2015-12-04
N207930-00181828382028-10-20Drug product2015-12-04

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 UTC2026-02N207930-001UTIBRON NEOHALER15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207930-001UTIBRON NEOHALER15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N207930-001UTIBRON NEOHALER15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD, RS2015-10-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD, RS2015-10-293f01610625f2…
2019-09-15 20:21 UTC2019-09N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD, RS2015-10-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD, RS2015-10-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-293f0d92c62455…
2023-05-13 08:27 UTC2023-05N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29053a50430f4f…
2023-01-26 05:58 UTC2023-01N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N207930-001UTIBRON15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 7 · 241 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N207930-00184797302028-10-11Drug product2015-12-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207930-00181828382028-10-20Drug product2015-12-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207930-00168787212025-02-25U-1773Drug substance, Drug product2015-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207930-00184797302028-10-11Drug product2015-12-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207930-00181828382028-10-20Drug product2015-12-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N207930-00168787212025-02-25U-1773Drug substance, Drug product2015-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207930-00184797302028-10-11Drug product2015-12-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207930-00181828382028-10-20Drug product2015-12-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207930-00168787212025-02-25U-1773Drug substance, Drug product2015-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207930-00184797302028-10-11Drug product2015-12-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207930-00181828382028-10-20Drug product2015-12-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207930-00168787212025-02-25U-1773Drug substance, Drug product2015-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207930-00184797302028-10-11Drug product2015-12-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207930-00181828382028-10-20Drug product2015-12-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207930-00168787212025-02-25U-1773Drug substance, Drug product2015-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207930-00184797302028-10-11Drug product2015-12-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207930-00181828382028-10-20Drug product2015-12-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207930-00168787212025-02-25U-1773Drug substance, Drug product2015-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207930-00184797302028-10-11Drug product2015-12-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207930-00181828382028-10-20Drug product2015-12-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207930-00168787212025-02-25U-1773Drug substance, Drug product2015-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207930-00184797302028-10-11Drug product2015-12-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207930-00181828382028-10-20Drug product2015-12-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207930-00168787212025-02-25U-1773Drug substance, Drug product2015-12-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207930-00184797302028-10-11Drug product2015-12-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207930-00181828382028-10-20Drug product2015-12-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207930-00168787212025-02-25U-1773Drug substance, Drug product2015-12-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N207930-00184797302028-10-11Drug product2015-12-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N207930-00181828382028-10-20Drug product2015-12-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207930-00168787212025-02-25U-1773Drug substance, Drug product2015-12-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207930-00184797302028-10-11Drug product2015-12-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207930-00181828382028-10-20Drug product2015-12-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207930-00168787212025-02-25U-1773Drug substance, Drug product2015-12-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207930-00184797302028-10-11Drug product2015-12-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207930-00181828382028-10-20Drug product2015-12-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207930-00168787212025-02-25U-1773Drug substance, Drug product2015-12-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207930-00184797302028-10-11Drug product2015-12-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207930-00181828382028-10-20Drug product2015-12-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207930-00168787212025-02-25U-1773Drug substance, Drug product2015-12-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N207930-00184797302028-10-11Drug product2015-12-048072bd15b7f6…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0664UTIBRON NEOHALERindacaterol and glycopyrrolateNovartis Pharmaceuticals CorporationNDACurrent
63402-681UTIBRON NEOHALERINDACATEROL MALEATE and GLYCOPYRROLATESunovion Pharmaceuticals Inc.NDACurrent
63402-681UTIBRON NEOHALERINDACATEROL MALEATE and GLYCOPYRROLATESunovion Pharmaceuticals Inc.NDACurrent
63402-681UTIBRON NEOHALERINDACATEROL MALEATE and GLYCOPYRROLATESunovion Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68259SUPPL2021-08-02
68258SUPPL2021-08-02
68253SUPPL2021-08-02
68252SUPPL2021-08-02
58940SUPPL2019-06-04
58900SUPPL2019-05-31
47007SUPPL2017-01-30
46972SUPPL2017-01-25
45969ORIG2016-11-29
40595ORIG2015-11-04
10628ORIG2015-11-03