FDA.reportPublic FDA data

Application 021077

Type
NDA
Sponsor
GLAXO GRP LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADVAIR DISKUS 100/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.1MG/INH;EQ 0.05MG BASE/INHYesYes
002ADVAIR DISKUS 250/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.25MG/INH;EQ 0.05MG BASE/INHYesYes
003ADVAIR DISKUS 500/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.5MG/INH;EQ 0.05MG 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
N021077-001ADVAIR DISKUS 100/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24
N021077-002ADVAIR DISKUS 250/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24
N021077-003ADVAIR DISKUS 500/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N021077-001AB
N021077-002AB
N021077-003AB

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 UTC2026-02N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021077-002ADVAIR DISKUS 250/500.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021077-003ADVAIR DISKUS 500/500.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021077-001ADVAIR DISKUS 100/500.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONABRLD, RS2000-08-248072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021077-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021077-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021077-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021077-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021077-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021077-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021077-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021077-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021077-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021077-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021077-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021077-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021077-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021077-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021077-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021077-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021077-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021077-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021077-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021077-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021077-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021077-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021077-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021077-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021077-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021077-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021077-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021077-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021077-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021077-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021077-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021077-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021077-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021077-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021077-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021077-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021077-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021077-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021077-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021077-001AB18072bd15b7f6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N021077-001M-2142020-12-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021077-002M-2142020-12-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021077-003M-2142020-12-2074a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021077-001M-2142020-12-208869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021077-002M-2142020-12-208869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021077-003M-2142020-12-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021077-001M-2142020-12-20c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021077-002M-2142020-12-20c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021077-003M-2142020-12-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021077-001M-2142020-12-203f01610625f2…
2019-12-14 00:12 UTC2019-12N021077-002M-2142020-12-203f01610625f2…
2019-12-14 00:12 UTC2019-12N021077-003M-2142020-12-203f01610625f2…
2019-09-15 20:21 UTC2019-09N021077-001M-2142020-12-20b00525d2431f…
2019-09-15 20:21 UTC2019-09N021077-002M-2142020-12-20b00525d2431f…
2019-09-15 20:21 UTC2019-09N021077-003M-2142020-12-20b00525d2431f…
2019-07-19 19:46 UTC2019-07N021077-001M-2142020-12-20ea99ee380514…
2019-07-19 19:46 UTC2019-07N021077-002M-2142020-12-20ea99ee380514…
2019-07-19 19:46 UTC2019-07N021077-003M-2142020-12-20ea99ee380514…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutionscf306656-0d4c-4edd-9d6a-3471f99484e62026-04-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ndc (product): 50090-0731
ndc (product): 50090-0730
ndc (product): 50090-0732
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLGlaxoSmithKline LLC4eeb5f6a-593f-4a9e-9692-adefa2caf8fc2026-03-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ndc (product): 0173-0697
ndc (product): 0173-0695
ndc (product): 0173-0696
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLREMEDYREPACK INC.0a2d1344-f412-41db-9b54-0c92a07437032026-02-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutions17dd0a86-8161-4aa9-9b90-a23d81b381642025-08-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLREMEDYREPACK INC.197b7628-71aa-4fa2-94df-d617c0f2c9862025-08-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLREMEDYREPACK INC.1ce604aa-2535-4a3c-a64d-092f5d4f81942025-08-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutions7c9c722b-68ac-4bda-ad99-50e3fb1c58c82024-01-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutions9e237635-6975-4930-9ce1-051d9e3bf6152024-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ndc (product): 50090-4213
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLPrasco Laboratories6eb6ddac-fa26-43b3-bf3e-5b7b58138fdc2023-07-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ndc (product): 66993-584
ndc (product): 66993-585
ndc (product): 66993-586
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutionsa6d87760-4744-41d5-bfee-db3b996b72942023-05-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutions2dfadeac-6599-41c5-8e25-5f78cba17f002023-02-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ndc (product): 50090-4211
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutionsccf98c0a-fc40-4e08-bdf2-145fe4537db52023-02-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ndc (product): 50090-4214
Fluticasone Propionate and Salmeterol DISKUSFLUTICASONE PROPIONATE AND SALMETEROLProficient Rx LP6915bd5d-b792-4b1b-8221-7eeb0a8638ba2020-01-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021077
application number: NDA021077
ndc (product): 71205-262

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 73 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0695ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0695ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0695ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0695ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0695ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0695ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0696ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0696ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0696ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0696ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0696ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0696ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0697ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0697ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0697ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0697ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0697ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0697ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
21695-196ADVAIRfluticasone propionate and salmeterolRebel Distributors Corp.NDACurrent
21695-197ADVAIRfluticasone propionate and salmeterolRebel Distributors Corp.NDACurrent
21695-361ADVAIRfluticasone propionate and salmeterolRebel Distributors CorpNDACurrent
33261-873ADVAIRfluticasone propionate and salmeterolAidarex Pharmaceuticals LLCNDACurrent
33261-874ADVAIRfluticasone propionate and salmeterolAidarex Pharmaceuticals LLCNDACurrent
50090-0730ADVAIRfluticasone propionate and salmeterolA-S Medication SolutionsNDACurrent
50090-0731ADVAIRfluticasone propionate and salmeterolA-S Medication SolutionsNDACurrent
50090-0731ADVAIRfluticasone propionate and salmeterolA-S Medication SolutionsNDACurrent
50090-0732ADVAIRfluticasone propionate and salmeterolA-S Medication SolutionsNDACurrent
50090-4211Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4211Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4211Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4211Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4213Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4213Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4213Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4213Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4214Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4214Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4214Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4214Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
66993-584Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-584Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-584Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-584Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-584Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-584Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-585Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-585Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-585Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-585Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-585Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-585Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-586Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-586Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-586Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-586Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-586Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-586Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
68258-3031ADVAIRfluticasone propionate and salmeterolDispensing Solutions Inc.NDACurrent
70518-0508ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0508ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0514ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0514ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0514ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0514ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0538ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0538ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0538ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0538ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0538ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0538ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
71205-262Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolProficient Rx LPNDA AUTHORIZED GENERICCurrent
71205-262Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolProficient Rx LPNDA AUTHORIZED GENERICCurrent
71205-262Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolProficient Rx LPNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57517SUPPL2019-02-13
57132SUPPL2019-01-08
50882SUPPL2017-12-27
50881SUPPL2017-12-27
50828SUPPL2017-12-21
50827SUPPL2017-12-21
62320SUPPL2017-12-20
62319SUPPL2017-12-20
47493SUPPL2017-03-08
47458SUPPL2017-03-03
44470SUPPL2016-06-23
14304SUPPL2016-05-05
4233SUPPL2016-05-02
41933SUPPL2015-11-18
14303SUPPL2014-12-20
4232SUPPL2014-11-14
44994SUPPL2014-06-17
26660SUPPL2014-04-16
14302SUPPL2014-04-16
21421SUPPL2013-08-06
41932SUPPL2012-10-12
26659SUPPL2012-08-13
4231SUPPL2011-07-05
26658SUPPL2011-05-12
4229SUPPL2011-01-07
4230SUPPL2010-06-29
14301SUPPL2010-06-28
4228SUPPL2009-04-03
21420SUPPL2008-08-01
44636SUPPL2008-07-16
14300SUPPL2008-05-02
26657SUPPL2008-05-01
41931SUPPL2007-09-24
26655SUPPL2007-03-01
14298SUPPL2007-02-26
4227SUPPL2006-10-02
36026SUPPL2006-09-28
26656SUPPL2006-03-23
14299SUPPL2006-03-03
23623ORIG2005-11-30
36025SUPPL2004-10-04
26654SUPPL2004-10-04
36024SUPPL2004-05-04
26652SUPPL2004-04-29
36023SUPPL2003-12-02
26651SUPPL2003-11-25
21419ORIG2003-08-28
26653SUPPL2003-08-15
14297SUPPL2003-08-15
4226SUPPL2002-08-21