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 44.

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N207930-001UTIBRON NEOHALER15.6MCG/INH;27.5MCG/INHPOWDER / INHALATIONRLD2015-10-29a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 7 · 247 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N207930-00184797302028-10-11Drug product2015-12-04c2088c7a36db…
2026-10-15 13:18:302026-09N207930-00181828382028-10-20Drug product2015-12-04c2088c7a36db…
2026-09-14 22:38:342026-08N207930-00184797302028-10-11Drug product2015-12-0484e616aacf4f…
2026-09-14 22:38:342026-08N207930-00181828382028-10-20Drug product2015-12-0484e616aacf4f…
2026-08-18 06:07:402026-07N207930-00184797302028-10-11Drug product2015-12-04caaa826d4ba7…
2026-08-18 06:07:402026-07N207930-00181828382028-10-20Drug product2015-12-04caaa826d4ba7…
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…

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 · 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