FDA.reportPublic FDA data

Application 208891

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WIXELA INHUBFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.1MG/INH;EQ 0.05MG BASE/INHNoNo
002WIXELA INHUBFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.25MG/INH;EQ 0.05MG BASE/INHNoNo
003WIXELA INHUBFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.5MG/INH;EQ 0.05MG BASE/INHNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208891-001WIXELA INHUBFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30
A208891-002WIXELA INHUBFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30
A208891-003WIXELA INHUBFLUTICASONE PROPIONATE; SALMETEROL XINAFOATE0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208891-001AB
A208891-002AB
A208891-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-3084e616aacf4f…
2026-09-14 22:38:342026-08A208891-002WIXELA INHUB0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-3084e616aacf4f…
2026-09-14 22:38:342026-08A208891-003WIXELA INHUB0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-3084e616aacf4f…
2026-08-18 06:07:402026-07A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07A208891-002WIXELA INHUB0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30caaa826d4ba7…
2026-08-18 06:07:402026-07A208891-003WIXELA INHUB0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208891-002WIXELA INHUB0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208891-003WIXELA INHUB0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208891-002WIXELA INHUB0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208891-003WIXELA INHUB0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208891-002WIXELA INHUB0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208891-003WIXELA INHUB0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208891-002WIXELA INHUB0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208891-003WIXELA INHUB0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208891-002WIXELA INHUB0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208891-003WIXELA INHUB0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208891-002WIXELA INHUB0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208891-003WIXELA INHUB0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208891-002WIXELA INHUB0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208891-003WIXELA INHUB0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208891-002WIXELA INHUB0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208891-003WIXELA INHUB0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208891-002WIXELA INHUB0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208891-003WIXELA INHUB0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A208891-002WIXELA INHUB0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A208891-003WIXELA INHUB0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208891-002WIXELA INHUB0.25MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208891-003WIXELA INHUB0.5MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208891-001WIXELA INHUB0.1MG/INH;EQ 0.05MG BASE/INHPOWDER / INHALATIONAB2019-01-30301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208891-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208891-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208891-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A208891-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208891-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208891-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208891-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208891-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208891-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208891-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208891-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208891-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208891-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208891-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208891-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208891-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208891-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208891-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208891-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208891-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208891-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208891-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208891-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208891-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208891-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208891-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208891-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208891-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208891-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208891-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208891-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208891-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208891-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208891-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208891-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208891-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208891-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208891-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208891-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208891-001AB1301d65b070ca…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Wixela InhubFLUTICASONE PROPIONATE AND SALMETEROLBryant Ranch Prepack6a5e28ef-3bbb-43a6-b599-499b3c6076c92025-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208891
application number: ANDA208891
Wixela InhubFLUTICASONE PROPIONATE AND SALMETEROLMylan Pharmaceuticals Inc.3beef422-8a07-4a45-9ba6-414511e4b7e22022-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208891
application number: ANDA208891
ndc (product): 0378-9322
ndc (product): 0378-9321
ndc (product): 0378-9320

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-9320Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9320Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9320Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9320Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9321Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9321Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9321Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9321Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9322Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9322Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9322Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
0378-9322Wixela Inhubfluticasone propionate and salmeterolMylan Pharmaceuticals Inc.ANDACurrent
70518-2501Wixela Inhubfluticasone propionate and salmeterolREMEDYREPACK INC.ANDACurrent
70518-2501Wixela Inhubfluticasone propionate and salmeterolREMEDYREPACK INC.ANDACurrent
70518-2501Wixela Inhubfluticasone propionate and salmeterolREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71467ORIG2022-06-28
57717ORIG2019-02-21
57452ORIG2019-02-06