Application 021254

Type
NDA
Sponsor
GLAXO GRP LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADVAIR HFAFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEAEROSOL, METERED;INHALATION0.045MG/INH;EQ 0.021MG BASE/INHYesYes
002ADVAIR HFAFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEAEROSOL, METERED;INHALATION0.115MG/INH;EQ 0.021MG BASE/INHYesYes
003ADVAIR HFAFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEAEROSOL, METERED;INHALATION0.23MG/INH;EQ 0.021MG BASE/INHYesYes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021254-001ADVAIR HFAFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08
N021254-002ADVAIR HFAFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08
N021254-003ADVAIR HFAFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021254-002ADVAIR HFA0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021254-003ADVAIR HFA0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021254-002ADVAIR HFA0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021254-003ADVAIR HFA0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021254-002ADVAIR HFA0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021254-003ADVAIR HFA0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021254-002ADVAIR HFA0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021254-003ADVAIR HFA0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021254-002ADVAIR HFA0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021254-003ADVAIR HFA0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021254-002ADVAIR HFA0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021254-003ADVAIR HFA0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021254-002ADVAIR HFA0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021254-003ADVAIR HFA0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021254-002ADVAIR HFA0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021254-003ADVAIR HFA0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021254-002ADVAIR HFA0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021254-003ADVAIR HFA0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N021254-002ADVAIR HFA0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N021254-003ADVAIR HFA0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021254-002ADVAIR HFA0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021254-003ADVAIR HFA0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021254-002ADVAIR HFA0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021254-003ADVAIR HFA0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021254-002ADVAIR HFA0.115MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021254-003ADVAIR HFA0.23MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021254-001ADVAIR HFA0.045MG/INH;EQ 0.021MG BASE/INHAEROSOL, METERED / INHALATIONRLD, RS2006-06-088072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 9 · 326 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021254-00178323512023-06-19Drug product2012-09-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021254-0017832351*PED2023-12-19Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021254-00175004442026-02-26Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021254-0017500444*PED2026-08-26Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021254-00278323512023-06-19Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021254-0027832351*PED2023-12-19Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021254-00275004442026-02-26Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021254-0027500444*PED2026-08-26Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021254-00378323512023-06-19Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021254-0037832351*PED2023-12-19Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021254-00375004442026-02-26Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021254-0037500444*PED2026-08-26Pediatric extension5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021254-00178323512023-06-19Drug product2012-09-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021254-0017832351*PED2023-12-19Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021254-00175004442026-02-26Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021254-0017500444*PED2026-08-26Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021254-00278323512023-06-19Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021254-0027832351*PED2023-12-19Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021254-00275004442026-02-26Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021254-0027500444*PED2026-08-26Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021254-00378323512023-06-19Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021254-0037832351*PED2023-12-19Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021254-00375004442026-02-26Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021254-0037500444*PED2026-08-26Pediatric extension5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021254-00178323512023-06-19Drug product2012-09-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021254-0017832351*PED2023-12-19Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021254-00175004442026-02-26Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021254-0017500444*PED2026-08-26Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021254-00278323512023-06-19Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021254-0027832351*PED2023-12-19Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021254-00275004442026-02-26Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021254-0027500444*PED2026-08-26Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021254-00378323512023-06-19Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021254-0037832351*PED2023-12-19Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021254-00375004442026-02-26Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021254-0037500444*PED2026-08-26Pediatric extension4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021254-0017350676*PED2019-02-24Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021254-00198617712020-10-11Drug product2018-03-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021254-00178323512023-06-19Drug product2012-09-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021254-0017832351*PED2023-12-19Pediatric extension74a2ff9319b5…

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
ADVAIR HFAFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEA-S Medication Solutions80b36523-4ae4-463e-b1fd-b929fb802b762025-08-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 021254
application number: NDA021254
ADVAIR HFAFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEA-S Medication Solutions223fd5d4-3bd2-4e45-b72e-699438c322062025-08-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 021254
application number: NDA021254
Fluticasone Propionate and Salmeterol HFAFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEPrasco Laboratories666c5b12-a4f7-4c53-8261-4742b5e5a6df2024-05-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 021254
application number: NDA021254
ADVAIR HFAFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEGlaxoSmithKline LLCdfaca6f9-3277-47b2-319d-1377917cb54c2024-05-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 021254
application number: NDA021254
ndc (product): 0173-0717
ndc (product): 0173-0716
ndc (product): 0173-0715

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0715ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0715ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0715ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0715ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0715ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0715ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0716ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0716ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0716ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0716ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0716ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0716ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0717ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0717ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0717ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0717ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0717ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent
0173-0717ADVAIR HFAfluticasone propionate and salmeterol xinafoateGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68420SUPPL2021-08-19
68408SUPPL2021-08-19
57518SUPPL2019-02-13
57131SUPPL2019-01-08
50875SUPPL2017-12-27
50841SUPPL2017-12-22
47492SUPPL2017-03-08
47457SUPPL2017-03-03
36479SUPPL2014-12-20
4798SUPPL2014-12-12
36480SUPPL2014-12-11
4797SUPPL2014-11-14
27227SUPPL2012-12-21
14761SUPPL2012-12-21
4796SUPPL2012-08-13
27231SUPPL2011-07-05
36478SUPPL2011-05-16
27230SUPPL2011-05-12
27228SUPPL2011-01-07
27229SUPPL2010-06-29
14762SUPPL2010-06-28
4795SUPPL2009-10-26
36477SUPPL2009-09-21
4794SUPPL2008-08-05
21551ORIG2008-05-06
36476SUPPL2008-03-24
4793SUPPL2008-03-21
23639ORIG2006-06-19
36475ORIG2006-06-14
4792ORIG2006-06-14
51121SUPPL1900-01-01
51120SUPPL1900-01-01
51119SUPPL1900-01-01