Application 207957
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | SPRAY, METERED;NASAL | 0.05MG/SPRAY | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207957-001 | FLUTICASONE PROPIONATE | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-05-26 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-05-26 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-05-26 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-05-26 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-05-26 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-05-26 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-05-26 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | 2016-05-26 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | e64feba35796… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 46122-386 | Good Neighbor Pharmacy Childrens Fluticasone Propionate | Fluticasone Propionate | Amerisource Bergen | ANDA | Current |
| 46122-684 | good neighbor pharmacy fluticasone propionate | Fluticasone propionate | Amerisource Bergen | ANDA | Current |
| 46122-684 | good neighbor pharmacy fluticasone propionate | Fluticasone propionate | Amerisource Bergen | ANDA | Current |
| 49035-200 | equate allergy relief | Fluticasone propionate | Wal-Mart Stores Inc | ANDA | Current |
| 49035-200 | equate allergy relief | Fluticasone propionate | Wal-Mart Stores Inc | ANDA | Current |
| 49035-200 | equate allergy relief | Fluticasone propionate | Wal-Mart Stores Inc | ANDA | Current |
| 49348-182 | SunMark allergy relief nasal 24 hr | Fluticasone propionate | Strategic Sourcing Services LLC | ANDA | Current |
| 49348-182 | SunMark allergy relief nasal 24 hr | Fluticasone propionate | Strategic Sourcing Services LLC | ANDA | Current |
| 49348-182 | SunMark allergy relief nasal 24 hr | Fluticasone propionate | Strategic Sourcing Services LLC | ANDA | Current |
| 49348-182 | SunMark allergy relief nasal 24 hr | Fluticasone propionate | Strategic Sourcing Services LLC | ANDA | Current |
| 49348-182 | SunMark allergy relief nasal 24 hr | Fluticasone propionate | Mckesson | ANDA | Current |
| 49738-303 | Smart Sense Allergy Relief | Fluticasone propionate | Kmart Corporation | ANDA | Current |
| 50594-319 | sound body allergy relief | Fluticasone propionate | Big Lots Stores, Inc. | ANDA | Current |
| 50594-319 | sound body allergy relief | Fluticasone propionate | Big Lots Stores, Inc. | ANDA | Current |
| 50594-319 | sound body allergy relief | Fluticasone propionate | Big Lots Stores, Inc. | ANDA | Current |
| 55301-506 | exchange select allergy relief | Fluticasone propionate | Army & Air Force Exchange Service | ANDA | Current |
| 55301-506 | exchange select allergy relief | Fluticasone propionate | Army & Air Force Exchange Service | ANDA | Current |
| 55301-506 | exchange select allergy relief | Fluticasone propionate | Army & Air Force Exchange Service | ANDA | Current |
| 55316-007 | Healthy Accents Nasoflow | Fluticasone propionate | DZA Brands LLC | ANDA | Current |
| 55316-719 | Healthy Accents Allergy Relief | Fluticasone propionate | DZA Brands LLC | ANDA | Current |
| 55319-019 | family wellness allergy relief nasal | Fluticasone propionate | Family Dollar Services Inc | ANDA | Current |
| 55319-019 | family wellness allergy relief nasal | Fluticasone propionate | Family Dollar Services Inc | ANDA | Current |
| 55319-019 | family wellness allergy relief nasal | Fluticasone propionate | Family Dollar Services Inc | ANDA | Current |
| 55319-019 | family wellness allergy relief nasal | Fluticasone propionate | Family Dollar Services Inc | ANDA | Current |
| 55319-019 | family wellness allergy relief nasal | Fluticasone propionate | Family Dollar Services Inc | ANDA | Current |
| 55910-607 | DG Health childrens allergy relief nasal | Fluticasone Propionate | Dolgencorp, LLC | ANDA | Current |
| 55910-607 | DG Health childrens allergy relief nasal | Fluticasone Propionate | Dolgencorp, LLC | ANDA | Current |
| 55910-773 | DG Health Allergy Relief Nasal | Fluticasone propionate | Dolgencorp, LLC | ANDA | Current |
| 55910-773 | DG Health Allergy Relief Nasal | Fluticasone propionate | Dolgencorp, LLC | ANDA | Current |
| 56062-007 | nasoflow | Fluticasone propionate | Publix Super Markets Inc | ANDA | Current |
| 56062-107 | allergy relief nasal | Fluticasone propionate | Publix Super Markets Inc | ANDA | Current |
| 56062-107 | allergy relief nasal | Fluticasone propionate | Publix Super Markets Inc | ANDA | Current |
| 56062-107 | allergy relief nasal | Fluticasone propionate | Publix Super Markets Inc | ANDA | Current |
| 57483-005 | FlutiCare | fluticasone propionate (glucocorticoid) | Innovus Pharmaceuticals Inc. | ANDA | Current |
| 57483-005 | FlutiCare | fluticasone propionate (glucocorticoid) | Innovus Pharmaceuticals Inc. | ANDA | Current |
| 57483-005 | FlutiCare | fluticasone propionate (glucocorticoid) | Innovus Pharmaceuticals Inc. | ANDA | Current |
| 57483-005 | FlutiCare | fluticasone propionate (glucocorticoid) | Innovus Pharmaceuticals Inc. | ANDA | Current |
| 62011-0269 | health mart allergy relief nasal 24 hr | Fluticasone propionate | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0269 | health mart allergy relief nasal 24 hr | Fluticasone propionate | Mckesson | ANDA | Current |
| 62011-0269 | health mart allergy relief nasal 24 hr | Fluticasone propionate | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0269 | health mart allergy relief nasal 24 hr | Fluticasone propionate | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0269 | health mart allergy relief nasal 24 hr | Fluticasone propionate | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0269 | health mart allergy relief nasal 24 hr | Fluticasone propionate | Strategic Sourcing Services LLC | ANDA | Current |
| 63940-501 | Core Values Allergy Relief | Fluticasone propionate | Harmon Stores Inc. | ANDA | Current |
| 63940-501 | Core Values Allergy Relief | Fluticasone propionate | Harmon Stores Inc. | ANDA | Current |
| 63940-501 | Core Values Allergy Relief | Fluticasone propionate | Harmon Stores Inc. | ANDA | Current |
| 63981-001 | Kirkland Signature Aller Flo | Fluticasone propionate | Costco Wholesale Company | ANDA | Current |
| 63981-001 | Kirkland Signature Aller Flo | Fluticasone propionate | Costco Wholesale Company | ANDA | Current |
| 63981-001 | Kirkland Signature Aller Flo | Fluticasone propionate | Costco Wholesale Company | ANDA | Current |
| 64024-007 | Welby Fluticasone | Fluticasone propionate | Aldi Inc | ANDA | Current |
| 64024-007 | Welby Fluticasone | Fluticasone propionate | Aldi Inc | ANDA | Current |
| 64024-007 | Welby Fluticasone | Fluticasone propionate | Aldi Inc | ANDA | Current |
| 64024-205 | welby allergy relief | Fluticasone propionate | Aldi, Inc | ANDA | Current |
| 68391-133 | Berkley and Jensen Allergy Relief | Fluticasone propionate | BJWC | ANDA | Current |
| 68391-133 | Berkley and Jensen Allergy Relief | Fluticasone propionate | BJWC | ANDA | Current |
| 68391-133 | Berkley and Jensen Allergy Relief | Fluticasone propionate | BJWC | ANDA | Current |
| 68391-133 | Berkley and Jensen Allergy Relief | Fluticasone propionate | BJWC | ANDA | Current |
| 69256-061 | Harris Teeter Allergy Relief Nasal | Fluticasone propionate | Harris Teeter, LLC | ANDA | Current |
| 69842-757 | FLUTICASONE PROPIONATE | Fluticasone Propionate | CVS Pharmacy | ANDA | Current |
| 69842-757 | FLUTICASONE PROPIONATE | Fluticasone Propionate | CVS Pharmacy | ANDA | Current |
| 69842-900 | Fluticasone Propionate Nasal | Fluticasone propionate | CVS Pharmacy | ANDA | Current |
| 69842-900 | Fluticasone Propionate Nasal | Fluticasone propionate | CVS Pharmacy | ANDA | Current |
| 69842-900 | Fluticasone Propionate Nasal | Fluticasone propionate | CVS Pharmacy | ANDA | Current |
| 70000-0110 | leader allergy relief nasal | Fluticasone propionate | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70000-0110 | leader allergy relief nasal | Fluticasone propionate | Cardinal Health 110, LLC. dba Leader | ANDA | Current |
| 70000-0110 | leader allergy relief nasal | Fluticasone propionate | Cardinal Health | ANDA | Current |
| 70518-2930 | RUGBY FLUTICASONE PROPIONATE NASAL | Fluticasone propionate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2930 | RUGBY FLUTICASONE PROPIONATE NASAL | Fluticasone propionate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2930 | RUGBY FLUTICASONE PROPIONATE NASAL | Fluticasone propionate | REMEDYREPACK INC. | ANDA | Current |
| 71141-012 | Nasal | Fluticasone propionate | Lidl US LLC | ANDA | Current |
| 72288-119 | basic care allergy relief nasal | Fluticasone propionate | Amazon.com Services LLC | ANDA | Current |
| 72288-119 | basic care allergy relief nasal | Fluticasone propionate | Amazon.com Services LLC | ANDA | Current |
| 72288-119 | basic care allergy relief nasal | Fluticasone propionate | Amazon.com Services LLC | ANDA | Current |
| 72288-333 | basic care childrens allergy relief nasal | Fluticasone Propionate | Amazon.com Services LLC | ANDA | Current |
| 79903-071 | Equate Allergy Relief | Fluticasone propionate | WALMART INC. | ANDA | Current |
| 79903-071 | Equate Allergy Relief | Fluticasone propionate | WALMART INC. | ANDA | Current |
| 80159-201 | Picnic Allergy Symptom Reliever Nasal | Fluticasone propionate | 30M One, Inc. | ANDA | Current |
| 80159-201 | Picnic Allergy Symptom Reliever Nasal | Fluticasone propionate | 30M One, Inc. | ANDA | Current |
| 80159-201 | Picnic Allergy Symptom Reliever Nasal | Fluticasone propionate | 30M One, Inc. | ANDA | Current |
| 80267-000 | betr allergy relief nasal | Fluticasone propionate | Live Betr LLC | ANDA | Current |