Application 204097
- Type
- ANDA
- Sponsor
- HETERO LABS LTD V
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 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 |
|---|---|---|---|---|---|---|---|
| A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2016-08-19 | ||
| A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2016-08-19 | ||
| A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2016-08-19 |
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 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|
| 0904-6978 | Allergy Relief | Fexofenadine HCL | Major Pharmaceuticals | ANDA | Current |
| 0904-6978 | Allergy Relief | Fexofenadine HCL | Major Pharmaceuticals | ANDA | Current |
| 16714-899 | Fexofenadine HCL | Fexofenadine HCL | NorthStar RxLLC | ANDA | Current |
| 16714-899 | Fexofenadine HCL | Fexofenadine HCL | NorthStar RxLLC | ANDA | Current |
| 21130-064 | Allergy Relief | Fexofenadine HCl | Safeway, Inc. | ANDA | Current |
| 21130-064 | Allergy Relief | Fexofenadine HCl | Safeway, Inc. | ANDA | Current |
| 21130-064 | Allergy Relief | Fexofenadine HCl | Safeway, Inc. | ANDA | Current |
| 41250-564 | Allergy Relief | Fexofenadine HCl | MEIJER, INC. | ANDA | Current |
| 41250-564 | Allergy Relief | Fexofenadine HCl | MEIJER, INC. | ANDA | Current |
| 41250-564 | Allergy Relief | Fexofenadine HCl | MEIJER, INC. | ANDA | Current |
| 49035-366 | equate allergy relief | fexofenadine hydrochloride | Walmart Inc. | ANDA | Current |
| 49035-366 | equate allergy relief | fexofenadine hydrochloride | Walmart Inc. | ANDA | Current |
| 49035-366 | equate allergy relief | fexofenadine hydrochloride | Walmart Inc. | ANDA | Current |
| 49035-504 | Allergy Relief | Fexofenadine HCL | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-504 | Allergy Relief | Fexofenadine HCL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | ANDA | Current |
| 49035-504 | Allergy Relief | Fexofenadine HCL | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 50090-4070 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4070 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4070 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4070 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4070 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4070 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4267 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4267 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 55700-848 | Fexofenadine HCL | Fexofenadine HCL | Quality Care Products, LLC | ANDA | Current |
| 55700-848 | Fexofenadine HCL | Fexofenadine HCL | Quality Care Products, LLC | ANDA | Current |
| 59726-564 | Allergy Relief | Fexofenadine HCL | P & L Development, LLC | ANDA | Current |
| 59726-564 | Allergy Relief | Fexofenadine HCL | P & L Development, LLC | ANDA | Current |
| 59726-564 | Allergy Relief | Fexofenadine HCL | P & L Development, LLC | ANDA | Current |
| 59726-564 | Allergy Relief | Fexofenadine HCL | P & L Development, LLC | ANDA | Current |
| 63548-0662 | Childrens Allergy Relief | Fexofenadine HCL | PLD Acquisitions LLC DBA Av | ANDA | Current |
| 63548-0663 | Allergy Relief | Fexofenadine HCl | PLD Acquisitions LLC DBA Av | ANDA | Current |
| 63548-0664 | Allergy Relief | Fexofenadine HCl | PLD Acquisitions LLC DBA Av | ANDA | Current |
| 63629-7997 | Fexofenadine HCL | Fexofenadine HCL | Bryant Ranch Prepack | ANDA | Current |
| 63941-064 | Allergy Relief | Fexofenadine HCL | Best Choice (Valu Merchandisers Company) | ANDA | Current |
| 63941-064 | Allergy Relief | Fexofenadine HCL | Best Choice (Valu Merchandisers Company) | ANDA | Current |
| 63941-064 | Allergy Relief | Fexofenadine HCL | Best Choice (Valu Merchandisers Company) | ANDA | Current |
| 68071-2682 | Fexofenadine HCL | Fexofenadine HCL | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2682 | Fexofenadine HCL | Fexofenadine HCL | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4846 | Fexofenadine HCL | Fexofenadine HCL | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4846 | Fexofenadine HCL | Fexofenadine HCL | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68554-5061 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Hetero Labs Limited | ANDA | Current |
| 68554-5062 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Hetero Labs Limited | ANDA | Current |
| 68554-5063 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Hetero Labs Limited | ANDA | Current |
| 68788-7449 | Fexofenadine HCL | Fexofenadine HCL | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7449 | Fexofenadine HCL | Fexofenadine HCL | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7449 | Fexofenadine HCL | Fexofenadine HCL | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7449 | Fexofenadine HCL | Fexofenadine HCL | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69230-300 | Fexofenadine HCL | Fexofenadine HCL | Camber Consumer Care | ANDA | Current |
| 69230-300 | Fexofenadine HCL | Fexofenadine HCL | Camber Consumer Care | ANDA | Current |
| 69230-301 | Fexofenadine HCL | Fexofenadine HCL | Camber Consumer Care | ANDA | Current |
| 69230-301 | Fexofenadine HCL | Fexofenadine HCL | Camber Consumer Care | ANDA | Current |
| 70934-601 | Fexofenadine HCL | Fexofenadine HCL | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-610 | Fexofenadine HCL | Fexofenadine HCL | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71205-531 | Fexofenadine HCL | Fexofenadine HCL | Proficient Rx LP | ANDA | Current |
| 71205-531 | Fexofenadine HCL | Fexofenadine HCL | Proficient Rx LP | ANDA | Current |
| 71335-1217 | Fexofenadine HCL | Fexofenadine HCL | Bryant Ranch Prepack | ANDA | Current |
| 71626-502 | Allergy Relief | Fexofenadine HCL | Medstone Pharma LLC | ANDA | Current |
| 71626-502 | Allergy Relief | Fexofenadine HCL | Medstone Pharma LLC | ANDA | Current |
| 71626-502 | Allergy Relief | Fexofenadine HCL | Medstone Pharma LLC | ANDA | Current |
| 71626-502 | Allergy Relief | Fexofenadine HCL | Medstone Pharma LLC | ANDA | Current |
| 71626-502 | Allergy Relief | Fexofenadine HCL | Medstone Pharma LLC | ANDA | Current |
| 71626-502 | Allergy Relief | Fexofenadine HCL | Medstone Pharma LLC | ANDA | Current |
| 72090-061 | Fex-Allergy Relief | Fexofenadine HCl | Pioneer Life Sciences, LLC | ANDA | Current |
| 72189-305 | Fexofenadine | Fexofenadine | DirectRx | ANDA | Current |
| 72789-196 | Fexofenadine HCL | Fexofenadine HCL | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-196 | Fexofenadine HCL | Fexofenadine HCL | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-196 | Fexofenadine HCL | Fexofenadine HCL | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |