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 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207957-001FLUTICASONE 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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207957-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASALRS2016-05-26cb3db0bc1861…

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 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ndc (product): 11822-0901
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
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
ndc (product): 41520-703
careone childrens allergy reliefFLUTICASONE PROPIONATEAmerican Sales Company45ffaf45-8b88-44ba-804b-c2b5635898982026-04-23WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
ndc (product): 41520-553
Up and Up Allergy Relief NasalFLUTICASONE PROPIONATETarget Corporation51c0a953-93cb-4d0a-b51c-02d9482d17462026-04-20WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
ndc (product): 11673-103
Good Sense 24 hour allergy nasalFLUTICASONE PROPIONATEL. Perrigo Company783ce1b9-27e4-428a-9f5e-04e70b234ac92026-04-09WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
ndc (product): 0113-0028
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
ndc (product): 37808-205
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
RUGBY FLUTICASONE PROPIONATE NASALFLUTICASONE PROPIONATESportpharm LLC95765842-415e-438b-8105-f6d93cddbdd02026-02-09WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
24 Hour Allergy NasalFLUTICASONE PROPIONATEWalgreen Company7698b73f-16f4-4b99-a3be-9453e8c354692026-02-05WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
ndc (product): 0363-0024
leader fluticasone propionateFLUTICASONE PROPIONATECardinal Health 110, LLC. dba Leader14bb5d74-0384-417e-a06b-8868d85234dd2026-01-21WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957
DG Health Allergy Relief NasalFLUTICASONE PROPIONATEDolgencorp Inc5f0514bd-7893-4602-a17b-716fb99475722026-01-21WarningsExact identifier
application applno (ANDA): 207957
application number: ANDA207957

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 166 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0028Good Sense 24 hour allergy nasalFluticasone propionateL. Perrigo CompanyANDACurrent
0113-0028Good Sense 24 hour allergy nasalFluticasone propionateL. Perrigo CompanyANDACurrent
0113-0028Good Sense 24 hour allergy nasalFluticasone propionateL. Perrigo CompanyANDACurrent
0113-0285Good Sense 24 hour allergy nasalFluticasone PropionateL. Perrigo CompanyANDACurrent
0113-0285Good Sense 24 hour allergy nasalFluticasone PropionateL. Perrigo CompanyANDACurrent
0113-0285Good Sense 24 hour allergy nasalFluticasone PropionateL. Perrigo CompanyANDACurrent
0113-7117basic care allergy relief nasalFluticasone propionateL. Perrigo CompanyANDACurrent
0363-002424 Hour Allergy NasalFluticasone propionateWalgreen CompanyANDACurrent
0363-002424 Hour Allergy NasalFluticasone propionateWalgreen CompanyANDACurrent
0363-002424 Hour Allergy NasalFluticasone propionateWalgreen CompanyANDACurrent
0363-002424 Hour Allergy NasalFluticasone propionateWalgreen CompanyANDACurrent
0363-002424 Hour Allergy NasalFluticasone propionateWalgreen CompanyANDACurrent
0363-0881Allergy NasalFluticasone PropionateWalgreen CompanyANDACurrent
0363-0881Allergy NasalFluticasone PropionateWalgreen CompanyANDACurrent
0363-0881Allergy NasalFluticasone PropionateWalgreen CompanyANDACurrent
0363-1205childrens nasalFluticasone PropionateWalgreen CompanyANDACurrent
0536-1183RUGBY FLUTICASONE PROPIONATE NASALFluticasone propionateRugby LaboratoriesANDACurrent
0536-1183RUGBY FLUTICASONE PROPIONATE NASALFluticasone propionateRugby LaboratoriesANDACurrent
0536-1183RUGBY FLUTICASONE PROPIONATE NASALFluticasone propionateRugby LaboratoriesANDACurrent
0536-1183RUGBY FLUTICASONE PROPIONATE NASALFluticasone propionateRugby LaboratoriesANDACurrent
11673-103Up and Up Allergy Relief NasalFluticasone propionateTarget CorporationANDACurrent
11673-103Up and Up Allergy Relief NasalFluticasone propionateTarget CorporationANDACurrent
11673-103Up and Up Allergy Relief NasalFluticasone propionateTarget CorporationANDACurrent
11673-103Up and Up Allergy Relief NasalFluticasone propionateTarget CorporationANDACurrent
11673-103Up and Up Allergy Relief NasalFluticasone propionateTarget CorporationANDACurrent
11673-103Up and Up Allergy Relief NasalFluticasone propionateTarget CorporationANDACurrent
11673-388Up and Up allergy relief nasalFluticasone PropionateTarget CorporationANDACurrent
11822-0901allergy nasalFluticasone propionateRite Aid CorporationANDACurrent
11822-0901allergy nasalFluticasone propionateRite Aid CorporationANDACurrent
11822-0901allergy nasalFluticasone propionateRite Aid CorporationANDACurrent
11822-1177childrens allergy nasalFluticasone PropionateRite Aid CorporationANDACurrent
11822-1177childrens allergy nasalFluticasone PropionateRite Aid CorporationANDACurrent
21130-089Signature Care Allergy ReliefFluticasone propionateSafewayANDACurrent
21130-089Signature Care Allergy ReliefFluticasone propionateSafewayANDACurrent
21130-089Signature Care Allergy ReliefFluticasone propionateSafewayANDACurrent
21130-089Signature Care Allergy ReliefFluticasone propionateSafewayANDACurrent
21130-089Signature Care Allergy ReliefFluticasone propionateSafewayANDACurrent
21130-122signature care childrens allergy reliefFluticasone PropionateSafewayANDACurrent
21130-122signature care childrens allergy reliefFluticasone PropionateSafewayANDACurrent
21130-122signature care childrens allergy reliefFluticasone PropionateSafewayANDACurrent
30142-30124 Hour Allergy Relief nasalFluticasone propionateKroger CompanyANDACurrent
30142-30124 Hour Allergy Relief nasalFluticasone propionateKroger CompanyANDACurrent
30142-387Childrens 24 Hour Allergy Relief NasalFluticasone PropionateKroger CompanyANDACurrent
30142-767allergy relief nasalFluticasone propionateKroger CompanyANDACurrent
30142-767allergy relief nasalFluticasone propionateKroger CompanyANDACurrent
36800-128TopCare Childrens Allergy Relief Nasal 24 HourFluticasone PropionateTopco Associates LLCANDACurrent
36800-128TopCare Childrens Allergy Relief Nasal 24 HourFluticasone PropionateTopco Associates LLCANDACurrent
36800-128TopCare Childrens Allergy Relief Nasal 24 HourFluticasone PropionateTopco Associates LLCANDACurrent
36800-128TopCare Childrens Allergy Relief Nasal 24 HourFluticasone PropionateTopco Associates LLCANDACurrent
36800-222topcare fluticasone propionate nasalFluticasone propionateTopco Associates LLCANDACurrent
36800-222topcare fluticasone propionate nasalFluticasone propionateTopco Associates LLCANDACurrent
36800-222topcare fluticasone propionate nasalFluticasone propionateTopco Associates LLCANDACurrent
36800-315TopCare Nasoflow Allergy ReliefFluticasone propionateTopco Associates LLCANDACurrent
37012-007NasoflowFluticasone propionateShopko Stores Operating Co., LLCANDACurrent
37012-30724 hour allergy nasalFluticasone propionateShopko Stores Operating Co., LLCANDACurrent
37808-075NasoflowFluticasone propionateH E BANDACurrent
37808-205Nasopro 24Fluticasone propionateH E BANDACurrent
37808-205Nasopro 24Fluticasone propionateH E BANDACurrent
37808-205Nasopro 24Fluticasone propionateH E BANDACurrent
37808-340Childrens Nasoprofluticasone propionateH E BANDACurrent
37808-340Childrens Nasoprofluticasone propionateH E BANDACurrent
37808-340Childrens Nasoprofluticasone propionateH E BANDACurrent
41163-023Equaline Fluticasone PropionateFluticasone propionateSupervalu IncANDACurrent
41163-023Equaline Fluticasone PropionateFluticasone propionateSupervalu IncANDACurrent
41163-023Equaline Fluticasone PropionateFluticasone propionateSupervalu IncANDACurrent
41163-100Equaline fluticasone propionateFluticasone PropionateSupervalu IncANDACurrent
41190-004ShopRite Allergy Relief NasalFluticasone propionateWakefern Food CorporationANDACurrent
41250-634Allergy ReliefFluticasone propionateMeijer Distribution IncANDACurrent
41250-634Allergy ReliefFluticasone propionateMeijer Distribution IncANDACurrent
41250-634Allergy ReliefFluticasone propionateMeijer Distribution IncANDACurrent
41250-93324 hour allergy relief nasalFluticasone propionateMeijer Distribution IncANDACurrent
41250-93324 hour allergy relief nasalFluticasone propionateMeijer Distribution IncANDACurrent
41250-93324 hour allergy relief nasalFluticasone propionateMeijer Distribution IncANDACurrent
41520-007careone fluticasone propionateFluticasone propionateAmerican Sales CompanyANDACurrent
41520-553careone childrens allergy reliefFluticasone PropionateAmerican Sales CompanyANDACurrent
41520-703CareOne Allergy ReliefFluticasone propionateAmerican Sales CompanyANDACurrent
41520-703CareOne Allergy ReliefFluticasone propionateAmerican Sales CompanyANDACurrent
42507-81824 Hour Allergy NasalFluticasone propionateHyVee IncANDACurrent
46122-338Good Neighbor Pharmacy Fluticasone PropionateFluticasone propionateAmerisource BergenANDACurrent
46122-338Good Neighbor Pharmacy Fluticasone PropionateFluticasone propionateAmerisource BergenANDACurrent