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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A207957-001 | FLUTICASONE PROPIONATE | 0.05MG/SPRAY | SPRAY, METERED / NASAL | RS | 2016-05-26 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|
| 0113-0028 | Good Sense 24 hour allergy nasal | Fluticasone propionate | L. Perrigo Company | ANDA | Current |
| 0113-0028 | Good Sense 24 hour allergy nasal | Fluticasone propionate | L. Perrigo Company | ANDA | Current |
| 0113-0028 | Good Sense 24 hour allergy nasal | Fluticasone propionate | L. Perrigo Company | ANDA | Current |
| 0113-0285 | Good Sense 24 hour allergy nasal | Fluticasone Propionate | L. Perrigo Company | ANDA | Current |
| 0113-0285 | Good Sense 24 hour allergy nasal | Fluticasone Propionate | L. Perrigo Company | ANDA | Current |
| 0113-0285 | Good Sense 24 hour allergy nasal | Fluticasone Propionate | L. Perrigo Company | ANDA | Current |
| 0113-7117 | basic care allergy relief nasal | Fluticasone propionate | L. Perrigo Company | ANDA | Current |
| 0363-0024 | 24 Hour Allergy Nasal | Fluticasone propionate | Walgreen Company | ANDA | Current |
| 0363-0024 | 24 Hour Allergy Nasal | Fluticasone propionate | Walgreen Company | ANDA | Current |
| 0363-0024 | 24 Hour Allergy Nasal | Fluticasone propionate | Walgreen Company | ANDA | Current |
| 0363-0024 | 24 Hour Allergy Nasal | Fluticasone propionate | Walgreen Company | ANDA | Current |
| 0363-0024 | 24 Hour Allergy Nasal | Fluticasone propionate | Walgreen Company | ANDA | Current |
| 0363-0881 | Allergy Nasal | Fluticasone Propionate | Walgreen Company | ANDA | Current |
| 0363-0881 | Allergy Nasal | Fluticasone Propionate | Walgreen Company | ANDA | Current |
| 0363-0881 | Allergy Nasal | Fluticasone Propionate | Walgreen Company | ANDA | Current |
| 0363-1205 | childrens nasal | Fluticasone Propionate | Walgreen Company | ANDA | Current |
| 0536-1183 | RUGBY FLUTICASONE PROPIONATE NASAL | Fluticasone propionate | Rugby Laboratories | ANDA | Current |
| 0536-1183 | RUGBY FLUTICASONE PROPIONATE NASAL | Fluticasone propionate | Rugby Laboratories | ANDA | Current |
| 0536-1183 | RUGBY FLUTICASONE PROPIONATE NASAL | Fluticasone propionate | Rugby Laboratories | ANDA | Current |
| 0536-1183 | RUGBY FLUTICASONE PROPIONATE NASAL | Fluticasone propionate | Rugby Laboratories | ANDA | Current |
| 11673-103 | Up and Up Allergy Relief Nasal | Fluticasone propionate | Target Corporation | ANDA | Current |
| 11673-103 | Up and Up Allergy Relief Nasal | Fluticasone propionate | Target Corporation | ANDA | Current |
| 11673-103 | Up and Up Allergy Relief Nasal | Fluticasone propionate | Target Corporation | ANDA | Current |
| 11673-103 | Up and Up Allergy Relief Nasal | Fluticasone propionate | Target Corporation | ANDA | Current |
| 11673-103 | Up and Up Allergy Relief Nasal | Fluticasone propionate | Target Corporation | ANDA | Current |
| 11673-103 | Up and Up Allergy Relief Nasal | Fluticasone propionate | Target Corporation | ANDA | Current |
| 11673-388 | Up and Up allergy relief nasal | Fluticasone Propionate | Target Corporation | ANDA | Current |
| 11822-0901 | allergy nasal | Fluticasone propionate | Rite Aid Corporation | ANDA | Current |
| 11822-0901 | allergy nasal | Fluticasone propionate | Rite Aid Corporation | ANDA | Current |
| 11822-0901 | allergy nasal | Fluticasone propionate | Rite Aid Corporation | ANDA | Current |
| 11822-1177 | childrens allergy nasal | Fluticasone Propionate | Rite Aid Corporation | ANDA | Current |
| 11822-1177 | childrens allergy nasal | Fluticasone Propionate | Rite Aid Corporation | ANDA | Current |
| 21130-089 | Signature Care Allergy Relief | Fluticasone propionate | Safeway | ANDA | Current |
| 21130-089 | Signature Care Allergy Relief | Fluticasone propionate | Safeway | ANDA | Current |
| 21130-089 | Signature Care Allergy Relief | Fluticasone propionate | Safeway | ANDA | Current |
| 21130-089 | Signature Care Allergy Relief | Fluticasone propionate | Safeway | ANDA | Current |
| 21130-089 | Signature Care Allergy Relief | Fluticasone propionate | Safeway | ANDA | Current |
| 21130-122 | signature care childrens allergy relief | Fluticasone Propionate | Safeway | ANDA | Current |
| 21130-122 | signature care childrens allergy relief | Fluticasone Propionate | Safeway | ANDA | Current |
| 21130-122 | signature care childrens allergy relief | Fluticasone Propionate | Safeway | ANDA | Current |
| 30142-301 | 24 Hour Allergy Relief nasal | Fluticasone propionate | Kroger Company | ANDA | Current |
| 30142-301 | 24 Hour Allergy Relief nasal | Fluticasone propionate | Kroger Company | ANDA | Current |
| 30142-387 | Childrens 24 Hour Allergy Relief Nasal | Fluticasone Propionate | Kroger Company | ANDA | Current |
| 30142-767 | allergy relief nasal | Fluticasone propionate | Kroger Company | ANDA | Current |
| 30142-767 | allergy relief nasal | Fluticasone propionate | Kroger Company | ANDA | Current |
| 36800-128 | TopCare Childrens Allergy Relief Nasal 24 Hour | Fluticasone Propionate | Topco Associates LLC | ANDA | Current |
| 36800-128 | TopCare Childrens Allergy Relief Nasal 24 Hour | Fluticasone Propionate | Topco Associates LLC | ANDA | Current |
| 36800-128 | TopCare Childrens Allergy Relief Nasal 24 Hour | Fluticasone Propionate | Topco Associates LLC | ANDA | Current |
| 36800-128 | TopCare Childrens Allergy Relief Nasal 24 Hour | Fluticasone Propionate | Topco Associates LLC | ANDA | Current |
| 36800-222 | topcare fluticasone propionate nasal | Fluticasone propionate | Topco Associates LLC | ANDA | Current |
| 36800-222 | topcare fluticasone propionate nasal | Fluticasone propionate | Topco Associates LLC | ANDA | Current |
| 36800-222 | topcare fluticasone propionate nasal | Fluticasone propionate | Topco Associates LLC | ANDA | Current |
| 36800-315 | TopCare Nasoflow Allergy Relief | Fluticasone propionate | Topco Associates LLC | ANDA | Current |
| 37012-007 | Nasoflow | Fluticasone propionate | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37012-307 | 24 hour allergy nasal | Fluticasone propionate | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37808-075 | Nasoflow | Fluticasone propionate | H E B | ANDA | Current |
| 37808-205 | Nasopro 24 | Fluticasone propionate | H E B | ANDA | Current |
| 37808-205 | Nasopro 24 | Fluticasone propionate | H E B | ANDA | Current |
| 37808-205 | Nasopro 24 | Fluticasone propionate | H E B | ANDA | Current |
| 37808-340 | Childrens Nasopro | fluticasone propionate | H E B | ANDA | Current |
| 37808-340 | Childrens Nasopro | fluticasone propionate | H E B | ANDA | Current |
| 37808-340 | Childrens Nasopro | fluticasone propionate | H E B | ANDA | Current |
| 41163-023 | Equaline Fluticasone Propionate | Fluticasone propionate | Supervalu Inc | ANDA | Current |
| 41163-023 | Equaline Fluticasone Propionate | Fluticasone propionate | Supervalu Inc | ANDA | Current |
| 41163-023 | Equaline Fluticasone Propionate | Fluticasone propionate | Supervalu Inc | ANDA | Current |
| 41163-100 | Equaline fluticasone propionate | Fluticasone Propionate | Supervalu Inc | ANDA | Current |
| 41190-004 | ShopRite Allergy Relief Nasal | Fluticasone propionate | Wakefern Food Corporation | ANDA | Current |
| 41250-634 | Allergy Relief | Fluticasone propionate | Meijer Distribution Inc | ANDA | Current |
| 41250-634 | Allergy Relief | Fluticasone propionate | Meijer Distribution Inc | ANDA | Current |
| 41250-634 | Allergy Relief | Fluticasone propionate | Meijer Distribution Inc | ANDA | Current |
| 41250-933 | 24 hour allergy relief nasal | Fluticasone propionate | Meijer Distribution Inc | ANDA | Current |
| 41250-933 | 24 hour allergy relief nasal | Fluticasone propionate | Meijer Distribution Inc | ANDA | Current |
| 41250-933 | 24 hour allergy relief nasal | Fluticasone propionate | Meijer Distribution Inc | ANDA | Current |
| 41520-007 | careone fluticasone propionate | Fluticasone propionate | American Sales Company | ANDA | Current |
| 41520-553 | careone childrens allergy relief | Fluticasone Propionate | American Sales Company | ANDA | Current |
| 41520-703 | CareOne Allergy Relief | Fluticasone propionate | American Sales Company | ANDA | Current |
| 41520-703 | CareOne Allergy Relief | Fluticasone propionate | American Sales Company | ANDA | Current |
| 42507-818 | 24 Hour Allergy Nasal | Fluticasone propionate | HyVee Inc | ANDA | Current |
| 46122-338 | Good Neighbor Pharmacy Fluticasone Propionate | Fluticasone propionate | Amerisource Bergen | ANDA | Current |
| 46122-338 | Good Neighbor Pharmacy Fluticasone Propionate | Fluticasone propionate | Amerisource Bergen | ANDA | Current |