Application 204507
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 180MG | No | No |
| 004 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 005 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 180MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2015-09-16 |
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 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | d06236e962d9… |
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 |
|---|---|---|---|---|---|
| 0363-0904 | Indoor Outdoor Allergy Relief | Fexofenadine HCl | Walgreens | ANDA | Current |
| 0363-0904 | Indoor Outdoor Allergy Relief | Fexofenadine HCl | Walgreens | ANDA | Current |
| 0363-0904 | Indoor Outdoor Allergy Relief | Fexofenadine HCl | Walgreens | ANDA | Current |
| 0363-0904 | Indoor Outdoor Allergy Relief | Fexofenadine HCl | Walgreens | ANDA | Current |
| 0363-9898 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | WALGREEN CO. | ANDA | Current |
| 0363-9898 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | WALGREEN CO. | ANDA | Current |
| 0363-9898 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | WALGREEN CO. | ANDA | Current |
| 0904-7050 | Fexofenadine Hydrochloride | Fexofenadine HCl | Major Pharmaceuticals | ANDA | Current |
| 0904-7050 | Fexofenadine Hydrochloride | Fexofenadine HCl | Major Pharmaceuticals | ANDA | Current |
| 0904-7050 | Fexofenadine Hydrochloride | Fexofenadine HCl | Major Pharmaceuticals | ANDA | Current |
| 0904-7050 | Fexofenadine Hydrochloride | Fexofenadine HCl | Major Pharmaceuticals | ANDA | Current |
| 0904-7192 | fexofenadine hcl | fexofenadine hcl | Major Pharmaceuticals | ANDA | Current |
| 21130-405 | IAllergy Relief | Fexofenadine HCl | Safeway, Inc. | ANDA | Current |
| 21130-405 | IAllergy Relief | Fexofenadine HCl | Safeway, Inc. | ANDA | Current |
| 36800-652 | Allergy Relief | Fexofenadine Hydrochloride | TopCo Associates LLC | ANDA | Current |
| 36800-652 | Allergy Relief | Fexofenadine Hydrochloride | TopCo Associates LLC | ANDA | Current |
| 41250-506 | Allergy Relief | Fexofenadine HCl | MEIJER, INC. | ANDA | Current |
| 41250-506 | Allergy Relief | Fexofenadine HCl | MEIJER, INC. | ANDA | Current |
| 41250-506 | Allergy Relief | Fexofenadine HCl | MEIJER, INC. | ANDA | Current |
| 41250-506 | Allergy Relief | Fexofenadine HCl | MEIJER, INC. | ANDA | Current |
| 49035-764 | Allergy Relief | Fexofenadine HCl | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-764 | Allergy Relief | Fexofenadine HCl | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 50090-2457 | Fexofenadine HCl | Fexofenadine HCl | A-S Medication Solutions | ANDA | Current |
| 50090-2457 | Fexofenadine HCl | Fexofenadine HCl | A-S Medication Solutions | ANDA | Current |
| 50228-201 | fexofenadine hcl | fexofenadine hcl | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-201 | fexofenadine hcl | fexofenadine hcl | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-202 | fexofenadine hcl | fexofenadine hcl | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-202 | fexofenadine hcl | fexofenadine hcl | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50594-504 | Allergy Relief | Fexofenadine HCl | Big Lots | ANDA | Current |
| 50594-504 | Allergy Relief | Fexofenadine HCl | Big Lots | ANDA | Current |
| 50594-769 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Big Lots Stores, Inc. | ANDA | Current |
| 50594-769 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Big Lots Stores, Inc. | ANDA | Current |
| 50594-769 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Big Lots Stores, Inc. | ANDA | Current |
| 50594-801 | Allergy Relief | Fexofenadine HCl | Big Lots | ANDA | Current |
| 50594-801 | Allergy Relief | Fexofenadine HCl | Big Lots | ANDA | Current |
| 50594-801 | Allergy Relief | Fexofenadine HCl | Big Lots | ANDA | Current |
| 50594-801 | Allergy Relief | Fexofenadine HCl | Big Lots | ANDA | Current |
| 51407-033 | fexofenadine hcl | fexofenadine hcl | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-033 | fexofenadine hcl | fexofenadine hcl | Golden State Medical Supply | ANDA | Current |
| 51407-034 | fexofenadine hcl | fexofenadine hcl | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-034 | fexofenadine hcl | fexofenadine hcl | Golden State Medical Supply | ANDA | Current |
| 51407-034 | fexofenadine hcl | fexofenadine hcl | Golden State Medical Supply | ANDA | Current |
| 53002-1409 | Fexofenadine HCl | Fexofenadine HCl | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1409 | Fexofenadine HCl | Fexofenadine HCl | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53943-192 | Allergy Relief | Fexofenadine Hydrochloride | DISCOUNT DRUG MART | ANDA | Current |
| 53943-192 | ALLERGY RELIEF | Fexofenadine Hydrochloride | DISCOUNT DRUG MART | ANDA | Current |
| 53943-192 | ALLERGY RELIEF | Fexofenadine Hydrochloride | DISCOUNT DRUG MART | ANDA | Current |
| 54257-170 | Allergy Relief | FEXOFENADINE HYDROCHLORIDE | Magno-Humphries, Inc. | ANDA | Current |
| 54257-170 | Allergy Relief | FEXOFENADINE HYDROCHLORIDE | Magno-Humphries, Inc. | ANDA | Current |
| 54257-170 | Allergy Relief | FEXOFENADINE HYDROCHLORIDE | Magno-Humphries, Inc. | ANDA | Current |
| 54257-702 | Allergy Relief | FEXOFENADINE HYDROCHLORIDE | Magno-Humphries, Inc. | ANDA | Current |
| 54257-702 | Allergy Relief | FEXOFENADINE HYDROCHLORIDE | Magno-Humphries, Inc. | ANDA | Current |
| 54257-702 | Allergy Relief | FEXOFENADINE HYDROCHLORIDE | Magno-Humphries, Inc. | ANDA | Current |
| 54257-702 | Allergy Relief | FEXOFENADINE HYDROCHLORIDE | Magno-Humphries, Inc. | ANDA | Current |
| 55700-500 | Fexofenadine HCl | Fexofenadine HCl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-500 | Fexofenadine HCl | Fexofenadine HCl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-500 | Fexofenadine HCl | Fexofenadine HCl | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57344-192 | Allergy Relief | Fexofenadine Hydrochloride | AAA Pharmaceutical, Inc. | ANDA | Current |
| 57344-192 | Allergy Relief | Fexofenadine Hydrochloride | AAA Pharmaceutical, Inc. | ANDA | Current |
| 59726-505 | Allergy Relief | Fexofenadine HCl | P & L Development, LLC | ANDA | Current |
| 59726-505 | Allergy Relief | Fexofenadine HCl | P & L Development, LLC | ANDA | Current |
| 59726-701 | IAllergy Relief | Fexofenadine HCl | P & L Development, LLC | ANDA | Current |
| 59726-701 | IAllergy Relief | Fexofenadine HCl | P & L Development, LLC | ANDA | Current |
| 59726-801 | Allergy Relief | Fexofenadine HCl | P & L Development, LLC | ANDA | Current |
| 59726-801 | Allergy Relief | Fexofenadine HCl | P & L Development, LLC | ANDA | Current |
| 59726-801 | Allergy Relief | Fexofenadine HCl | P & L Development, LLC | ANDA | Current |
| 59726-801 | Allergy Relief | Fexofenadine HCl | P & L Development, LLC | ANDA | Current |
| 59779-979 | Fexofenadine HCl | Fexofenadine HCl | CVS Pharmacy | ANDA | Current |
| 63187-921 | Fexofenadine HCl | Fexofenadine HCl | Proficient Rx LP | ANDA | Current |
| 63187-921 | Fexofenadine HCl | Fexofenadine HCl | Proficient Rx LP | ANDA | Current |
| 63868-667 | Allergy Relief | Fexofenadine Hydrochloride | CHAIN DRUG MARKETING ASSOCIATION INC. | ANDA | Current |
| 63868-667 | Allergy Relief | Fexofenadine Hydrochloride | CHAIN DRUG MARKETING ASSOCIATION INC. | ANDA | Current |
| 63940-768 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | HARMON STORES INC. | ANDA | Current |
| 63940-768 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | HARMON STORES INC. | ANDA | Current |
| 63940-769 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | HARMON STORES INC. | ANDA | Current |
| 63940-769 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | HARMON STORES INC. | ANDA | Current |
| 68016-176 | Allergy Relief | Fexofenadine Hydrochloride | CHAIN DRUG CONSORTIUM | ANDA | Current |
| 68016-176 | Allergy Relief | Fexofenadine Hydrochloride | CHAIN DRUG CONSORTIUM | ANDA | Current |
| 68016-769 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Pharmacy Value Alliance, LLC | ANDA | Current |
| 68016-769 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Pharmacy Value Alliance, LLC | ANDA | Current |