Application 207957

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATESPRAY, METERED;NASAL0.05MG/SPRAYNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207957-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-05-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-05-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-05-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-05-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-05-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-05-263f01610625f2…
2019-09-15 20:21 UTC2019-09A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-05-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2016-05-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26e64feba35796…

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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Childrens Allergy Relief Nasal 24 HourFLUTICASONE PROPIONATETopco Associates LLC3eeab9c9-82db-4d03-b4ba-34c1d6f1b1a92026-08-11WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
Good Sense 24 hour allergy nasalFLUTICASONE PROPIONATEL. Perrigo Company6f3f64e6-d1f8-40d7-bb25-f6f279db99872026-08-11WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
ALLERGY RELIEF NASALFLUTICASONE PROPIONATEAmazon.com Services LLCdc552613-5cfe-4de3-b2c0-79703316758a2026-07-30WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
allergy relief nasalFLUTICASONE PROPIONATEHyVee Incc3327be1-e4a9-4b02-968d-eff5e18cbc842026-06-03WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
allergy nasalFLUTICASONE PROPIONATERite Aid Corporatione471dacd-9b6e-4783-9a14-aa95d00cbc9c2026-06-03WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
Equate Childrens Allergy ReliefFLUTICASONE PROPIONATEWALMART INC.7e6949aa-66a7-4288-9990-3ad2ece1df3d2026-05-19WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
Fluticasone Propionate NasalFLUTICASONE PROPIONATECVS Pharmacycf2e16be-0126-412e-9ddd-013f97a7a7422026-05-08WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
ndc (product): 69842-900
childrens allergy reliefFLUTICASONE PROPIONATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4b1d223a-723b-4569-9505-da727691bc562026-04-29WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
CareOne Allergy ReliefFLUTICASONE PROPIONATEAmerican Sales Company587d7c72-a70e-4ada-945d-14989b96350c2026-04-23WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
careone childrens allergy reliefFLUTICASONE PROPIONATEAmerican Sales Company45ffaf45-8b88-44ba-804b-c2b5635898982026-04-23WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
Up and Up Allergy Relief NasalFLUTICASONE PROPIONATETarget Corporation51c0a953-93cb-4d0a-b51c-02d9482d17462026-04-20WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
Good Sense 24 hour allergy nasalFLUTICASONE PROPIONATEL. Perrigo Company783ce1b9-27e4-428a-9f5e-04e70b234ac92026-04-09WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
allergy reliefFLUTICASONE PROPIONATESafeway7b5547e1-af4d-4ba9-bd92-524aa11a0ecf2026-04-01WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
Nasopro 24FLUTICASONE PROPIONATEH E B8416eb8f-e7fc-4cae-9aa1-84b2321ad67e2026-03-10WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
RUGBY FLUTICASONE PROPIONATE NASALFLUTICASONE PROPIONATEA-S Medication Solutions0c4eb6cb-abc9-4945-8f30-cfa8b9eb579c2026-02-24WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
Topcare Allergy Relief NasalFLUTICASONE PROPIONATETopco Associates LLC4586256c-cc86-4792-92ef-5a65a35d63772026-02-19WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
ALLERGY RELIEFFLUTICASONE PROPIONATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED1a4f4449-a8d3-4c5b-8ba1-21223574545b2026-02-17WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
RUGBY FLUTICASONE PROPIONATE NASALFLUTICASONE PROPIONATEASCLEMED USA INC.e38d8796-b08c-49a8-94b8-0c2fdeb52a812026-02-10WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
exchange select allergy reliefFLUTICASONE PROPIONATEArmy & Air Force Exchange Servicef15d5c04-e308-4540-8c0a-d66a44c3d4fd2026-02-10WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
ndc (product): 55301-506
RUGBY FLUTICASONE PROPIONATE NASALFLUTICASONE PROPIONATESportpharm LLC95765842-415e-438b-8105-f6d93cddbdd02026-02-09WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957

NDC Listings For This Application#

NDC listings for this application page 2 of 3 · 166 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46122-386Good Neighbor Pharmacy Childrens Fluticasone PropionateFluticasone PropionateAmerisource BergenANDACurrent
46122-684good neighbor pharmacy fluticasone propionateFluticasone propionateAmerisource BergenANDACurrent
46122-684good neighbor pharmacy fluticasone propionateFluticasone propionateAmerisource BergenANDACurrent
49035-200equate allergy reliefFluticasone propionateWal-Mart Stores IncANDACurrent
49035-200equate allergy reliefFluticasone propionateWal-Mart Stores IncANDACurrent
49035-200equate allergy reliefFluticasone propionateWal-Mart Stores IncANDACurrent
49348-182SunMark allergy relief nasal 24 hrFluticasone propionateStrategic Sourcing Services LLCANDACurrent
49348-182SunMark allergy relief nasal 24 hrFluticasone propionateStrategic Sourcing Services LLCANDACurrent
49348-182SunMark allergy relief nasal 24 hrFluticasone propionateStrategic Sourcing Services LLCANDACurrent
49348-182SunMark allergy relief nasal 24 hrFluticasone propionateStrategic Sourcing Services LLCANDACurrent
49348-182SunMark allergy relief nasal 24 hrFluticasone propionateMckessonANDACurrent
49738-303Smart Sense Allergy ReliefFluticasone propionateKmart CorporationANDACurrent
50594-319sound body allergy reliefFluticasone propionateBig Lots Stores, Inc.ANDACurrent
50594-319sound body allergy reliefFluticasone propionateBig Lots Stores, Inc.ANDACurrent
50594-319sound body allergy reliefFluticasone propionateBig Lots Stores, Inc.ANDACurrent
55301-506exchange select allergy reliefFluticasone propionateArmy & Air Force Exchange ServiceANDACurrent
55301-506exchange select allergy reliefFluticasone propionateArmy & Air Force Exchange ServiceANDACurrent
55301-506exchange select allergy reliefFluticasone propionateArmy & Air Force Exchange ServiceANDACurrent
55316-007Healthy Accents NasoflowFluticasone propionateDZA Brands LLCANDACurrent
55316-719Healthy Accents Allergy ReliefFluticasone propionateDZA Brands LLCANDACurrent
55319-019family wellness allergy relief nasalFluticasone propionateFamily Dollar Services IncANDACurrent
55319-019family wellness allergy relief nasalFluticasone propionateFamily Dollar Services IncANDACurrent
55319-019family wellness allergy relief nasalFluticasone propionateFamily Dollar Services IncANDACurrent
55319-019family wellness allergy relief nasalFluticasone propionateFamily Dollar Services IncANDACurrent
55319-019family wellness allergy relief nasalFluticasone propionateFamily Dollar Services IncANDACurrent
55910-607DG Health childrens allergy relief nasalFluticasone PropionateDolgencorp, LLCANDACurrent
55910-607DG Health childrens allergy relief nasalFluticasone PropionateDolgencorp, LLCANDACurrent
55910-773DG Health Allergy Relief NasalFluticasone propionateDolgencorp, LLCANDACurrent
55910-773DG Health Allergy Relief NasalFluticasone propionateDolgencorp, LLCANDACurrent
56062-007nasoflowFluticasone propionatePublix Super Markets IncANDACurrent
56062-107allergy relief nasalFluticasone propionatePublix Super Markets IncANDACurrent
56062-107allergy relief nasalFluticasone propionatePublix Super Markets IncANDACurrent
56062-107allergy relief nasalFluticasone propionatePublix Super Markets IncANDACurrent
57483-005FlutiCarefluticasone propionate (glucocorticoid)Innovus Pharmaceuticals Inc.ANDACurrent
57483-005FlutiCarefluticasone propionate (glucocorticoid)Innovus Pharmaceuticals Inc.ANDACurrent
57483-005FlutiCarefluticasone propionate (glucocorticoid)Innovus Pharmaceuticals Inc.ANDACurrent
57483-005FlutiCarefluticasone propionate (glucocorticoid)Innovus Pharmaceuticals Inc.ANDACurrent
62011-0269health mart allergy relief nasal 24 hrFluticasone propionateStrategic Sourcing Services LLCANDACurrent
62011-0269health mart allergy relief nasal 24 hrFluticasone propionateMckessonANDACurrent
62011-0269health mart allergy relief nasal 24 hrFluticasone propionateStrategic Sourcing Services LLCANDACurrent
62011-0269health mart allergy relief nasal 24 hrFluticasone propionateStrategic Sourcing Services LLCANDACurrent
62011-0269health mart allergy relief nasal 24 hrFluticasone propionateStrategic Sourcing Services LLCANDACurrent
62011-0269health mart allergy relief nasal 24 hrFluticasone propionateStrategic Sourcing Services LLCANDACurrent
63940-501Core Values Allergy ReliefFluticasone propionateHarmon Stores Inc.ANDACurrent
63940-501Core Values Allergy ReliefFluticasone propionateHarmon Stores Inc.ANDACurrent
63940-501Core Values Allergy ReliefFluticasone propionateHarmon Stores Inc.ANDACurrent
63981-001Kirkland Signature Aller FloFluticasone propionateCostco Wholesale CompanyANDACurrent
63981-001Kirkland Signature Aller FloFluticasone propionateCostco Wholesale CompanyANDACurrent
63981-001Kirkland Signature Aller FloFluticasone propionateCostco Wholesale CompanyANDACurrent
64024-007Welby FluticasoneFluticasone propionateAldi IncANDACurrent
64024-007Welby FluticasoneFluticasone propionateAldi IncANDACurrent
64024-007Welby FluticasoneFluticasone propionateAldi IncANDACurrent
64024-205welby allergy reliefFluticasone propionateAldi, IncANDACurrent
68391-133Berkley and Jensen Allergy ReliefFluticasone propionateBJWCANDACurrent
68391-133Berkley and Jensen Allergy ReliefFluticasone propionateBJWCANDACurrent
68391-133Berkley and Jensen Allergy ReliefFluticasone propionateBJWCANDACurrent
68391-133Berkley and Jensen Allergy ReliefFluticasone propionateBJWCANDACurrent
69256-061Harris Teeter Allergy Relief NasalFluticasone propionateHarris Teeter, LLCANDACurrent
69842-757FLUTICASONE PROPIONATEFluticasone PropionateCVS PharmacyANDACurrent
69842-757FLUTICASONE PROPIONATEFluticasone PropionateCVS PharmacyANDACurrent
69842-900Fluticasone Propionate NasalFluticasone propionateCVS PharmacyANDACurrent
69842-900Fluticasone Propionate NasalFluticasone propionateCVS PharmacyANDACurrent
69842-900Fluticasone Propionate NasalFluticasone propionateCVS PharmacyANDACurrent
70000-0110leader allergy relief nasalFluticasone propionateCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0110leader allergy relief nasalFluticasone propionateCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0110leader allergy relief nasalFluticasone propionateCardinal HealthANDACurrent
70518-2930RUGBY FLUTICASONE PROPIONATE NASALFluticasone propionateREMEDYREPACK INC.ANDACurrent
70518-2930RUGBY FLUTICASONE PROPIONATE NASALFluticasone propionateREMEDYREPACK INC.ANDACurrent
70518-2930RUGBY FLUTICASONE PROPIONATE NASALFluticasone propionateREMEDYREPACK INC.ANDACurrent
71141-012NasalFluticasone propionateLidl US LLCANDACurrent
72288-119basic care allergy relief nasalFluticasone propionateAmazon.com Services LLCANDACurrent
72288-119basic care allergy relief nasalFluticasone propionateAmazon.com Services LLCANDACurrent
72288-119basic care allergy relief nasalFluticasone propionateAmazon.com Services LLCANDACurrent
72288-333basic care childrens allergy relief nasalFluticasone PropionateAmazon.com Services LLCANDACurrent
79903-071Equate Allergy ReliefFluticasone propionateWALMART INC.ANDACurrent
79903-071Equate Allergy ReliefFluticasone propionateWALMART INC.ANDACurrent
80159-201Picnic Allergy Symptom Reliever NasalFluticasone propionate30M One, Inc.ANDACurrent
80159-201Picnic Allergy Symptom Reliever NasalFluticasone propionate30M One, Inc.ANDACurrent
80159-201Picnic Allergy Symptom Reliever NasalFluticasone propionate30M One, Inc.ANDACurrent
80267-000betr allergy relief nasalFluticasone propionateLive Betr LLCANDACurrent