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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 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… |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68071-2615 | fexofenadine hcl | fexofenadine hcl | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4568 | Fexofenadine HCl | Fexofenadine HCl | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4568 | Fexofenadine HCl | Fexofenadine HCl | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4568 | Fexofenadine HCl | Fexofenadine HCl | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4568 | Fexofenadine HCl | Fexofenadine HCl | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4647 | Fexofenadine HCl | Fexofenadine HCl | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4647 | Fexofenadine HCl | Fexofenadine HCl | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68210-2210 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | SPIRIT PHARMACEUTICALS LLC | ANDA | Current |
| 68210-4090 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | SPIRIT PHARMACEUTICALS LLC | ANDA | Current |
| 68210-4090 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | SPIRIT PHARMACEUTICALS LLC | ANDA | Current |
| 68210-4090 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | SPIRIT PHARMACEUTICALS LLC | ANDA | Current |
| 68210-4090 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | SPIRIT PHARMACEUTICALS LLC | ANDA | Current |
| 68391-504 | Allergy Relief | Fexofenadine HCl | BJWC (Berkley & Jensen / BJ's) | ANDA | Current |
| 68391-504 | Allergy Relief | Fexofenadine HCl | BJWC (Berkley & Jensen / BJ's) | ANDA | Current |
| 68391-504 | Allergy Relief | Fexofenadine HCl | BJWC (Berkley & Jensen / BJ's) | ANDA | Current |
| 68391-504 | Allergy Relief | Fexofenadine HCl | BJWC (Berkley & Jensen / BJ's) | ANDA | Current |
| 68788-7089 | Fexofenadine HCl | Fexofenadine HCl | Preferred Pharmaceuticals | ANDA | Current |
| 68998-192 | Allergy Relief | Fexofenadine Hydrochloride | Marc Glassman, Inc. | ANDA | Current |
| 68998-192 | Allergy Relief | Fexofenadine Hydrochloride | Marc Glassman, Inc. | ANDA | Current |
| 69168-416 | Allergy Relief | Fexofenadine HCl | Allegiant Health | ANDA | Current |
| 69168-416 | Allergy Relief | Fexofenadine HCl | Allegiant Health | ANDA | Current |
| 69168-416 | Allergy Relief | Fexofenadine HCl | Allegiant Health | ANDA | Current |
| 69168-416 | Allergy Relief | Fexofenadine HCl | Allegiant Health | ANDA | Current |
| 69168-416 | Allergy Relief | Fexofenadine HCl | Allegiant Health | ANDA | Current |
| 69168-416 | Allergy Relief | Fexofenadine HCl | Allegiant Health | ANDA | Current |
| 69230-201 | Fexofenadine HCl | Fexofenadine HCl | Camber Consumer Care | ANDA | Current |
| 69230-202 | Fexofenadine HCl | Fexofenadine HCl | Camber Consumer Care | ANDA | Current |
| 69230-202 | Fexofenadine HCl | Fexofenadine HCl | Camber Consumer Care | ANDA | Current |
| 69848-002 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Granules USA, Inc | ANDA | Current |
| 69848-002 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Granules USA, Inc | ANDA | Current |
| 70518-2142 | Fexofenadine HCl | Fexofenadine HCl | REMEDYREPACK INC. | ANDA | Current |
| 70518-2142 | Fexofenadine HCl | Fexofenadine HCl | REMEDYREPACK INC. | ANDA | Current |
| 70518-2142 | Fexofenadine HCl | Fexofenadine HCl | REMEDYREPACK INC. | ANDA | Current |
| 70518-3088 | Fexofenadine Hydrochloride | Fexofenadine HCl | REMEDYREPACK INC. | ANDA | Current |
| 71335-0506 | Fexofenadine HCl | Fexofenadine HCl | Bryant Ranch Prepack | ANDA | Current |
| 71335-0506 | Fexofenadine HCl | Fexofenadine HCl | Bryant Ranch Prepack | ANDA | Current |
| 71335-0506 | Fexofenadine HCl | Fexofenadine HCl | Bryant Ranch Prepack | ANDA | Current |
| 71335-2165 | fexofenadine hcl | fexofenadine hcl | Bryant Ranch Prepack | ANDA | Current |
| 71399-8042 | Fexofenadine HCL | Fexofenadine HCL | Akron Pharma Inc. | ANDA | Current |
| 71399-8042 | Fexofenadine HCL | Fexofenadine HCL | Akron Pharma Inc. | ANDA | Current |
| 71399-8659 | fexofenadine hcl | fexofenadine hcl | AKRON PHARMA INC | ANDA | Current |
| 71610-070 | fexofenadine hcl | fexofenadine hcl | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-429 | Fexofenadine Hydrochloride | Fexofenadine HCl | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72036-192 | Allergy Relief | Fexofenadine Hydrochloride | Harris Teeter | ANDA | Current |
| 72036-192 | Allergy Relief | Fexofenadine Hydrochloride | Harris Teeter | ANDA | Current |
| 72036-192 | Allergy Relief | Fexofenadine Hydrochloride | Harris Teeter | ANDA | Current |
| 72036-192 | Allergy Relief | Fexofenadine Hydrochloride | Harris Teeter | ANDA | Current |
| 72559-004 | Curist Allergy Relief | Fexofenadine hydrochloride | Little Pharma, Inc. | ANDA | Current |
| 72559-004 | Curist Allergy Relief | Fexofenadine hydrochloride | Little Pharma, Inc. | ANDA | Current |
| 73581-011 | ALLERGY RELIEF | FEXOFENADINE HYDROCHLORIDE | YYBA CORP | ANDA | Current |
| 73581-011 | ALLERGY RELIEF | FEXOFENADINE HYDROCHLORIDE | YYBA CORP | ANDA | Current |
| 73581-011 | ALLERGY RELIEF | FEXOFENADINE HYDROCHLORIDE | YYBA CORP | ANDA | Current |
| 73581-011 | ALLERGY RELIEF | FEXOFENADINE HYDROCHLORIDE | YYBA CORP | ANDA | Current |
| 73581-011 | ALLERGY RELIEF | FEXOFENADINE HYDROCHLORIDE | YYBA CORP | ANDA | Current |
| 73581-103 | ALLERGY RELIEF | FEXOFENADINE HYDROCHLORIDE | YYBA CORP | ANDA | Current |
| 73581-103 | ALLERGY RELIEF | FEXOFENADINE HYDROCHLORIDE | YYBA CORP | ANDA | Current |
| 73581-103 | ALLERGY RELIEF | FEXOFENADINE HYDROCHLORIDE | YYBA CORP | ANDA | Current |
| 73581-103 | ALLERGY RELIEF | FEXOFENADINE HYDROCHLORIDE | YYBA CORP | ANDA | Current |
| 76519-1182 | FEXOFENADINE HCL | FEXOFENADINE HCL | H.J. Harkins Company, Inc. | ANDA | Current |
| 80539-504 | Allergy Relief | Fexofenadine HCl | Allwell Health Inc | ANDA | Current |
| 80539-504 | Allergy Relief | Fexofenadine HCl | Allwell Health Inc | ANDA | Current |
| 80539-504 | Allergy Relief | Fexofenadine HCl | Allwell Health Inc | ANDA | Current |