Application 076447
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 002 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 003 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 180MG | No | No |
| 004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 007 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 180MG | No | No |
| 009 | 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 |
|---|---|---|---|---|---|---|---|
| A076447-001 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-09-01 | ||
| A076447-002 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2005-09-01 | ||
| A076447-003 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2005-09-01 | ||
| A076447-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2011-04-13 | ||
| A076447-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2011-04-13 | ||
| A076447-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2011-04-13 | ||
| A076447-007 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2011-04-13 | ||
| A076447-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2011-04-13 |
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 | A076447-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-09-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2005-09-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2005-09-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076447-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-13 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2005-09-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2005-09-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2005-09-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076447-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-13 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076447-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2005-09-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076447-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2005-09-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076447-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2005-09-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076447-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076447-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076447-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076447-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076447-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-13 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2005-09-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2005-09-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2005-09-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-13 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076447-001 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2005-09-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076447-002 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2005-09-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076447-003 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2005-09-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076447-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-04-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076447-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-04-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076447-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-04-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076447-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-04-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076447-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-04-13 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076447-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076447-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076447-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076447-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076447-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076447-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076447-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076447-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076447-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076447-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076447-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076447-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076447-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076447-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076447-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076447-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076447-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076447-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076447-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076447-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076447-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076447-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076447-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076447-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076447-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076447-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076447-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076447-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076447-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076447-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076447-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076447-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076447-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076447-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076447-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076447-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076447-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076447-001 | AB | 1 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CareOne Allergy Relief | FEXOFENADINE HCL | American Sales Company | 65720e72-c20d-4363-92ab-76596e043bc0 | 2021-07-12 | Warnings | 076447 ANDA076447 |
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 |
|---|---|---|---|---|---|
| 62011-0413 | health mart fexofenadine hydrochloride | Fexofenadine Hydrochloride | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0471 | health mart allergy relief | Fexofenadine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 63187-334 | fexofenadine hydrochloride | fexofenadine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-334 | fexofenadine hydrochloride | fexofenadine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-334 | fexofenadine hydrochloride | fexofenadine hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-629 | Fexofenadine Hydrochloride | Fexofenadine HCl | Proficient Rx LP | ANDA | Current |
| 63187-629 | Fexofenadine Hydrochloride | Fexofenadine HCl | Proficient Rx LP | ANDA | Current |
| 63629-6897 | fexofenadine hydrochloride | fexofenadine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6897 | fexofenadine hydrochloride | fexofenadine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63981-571 | kirkland signature aller fex | fexofenadine hydrochloride | Costco Wholesale Company | ANDA | Current |
| 63981-571 | kirkland signature aller fex | fexofenadine hydrochloride | Costco Wholesale Company | ANDA | Current |
| 63981-571 | kirkland signature aller fex | fexofenadine hydrochloride | Costco Wholesale Company | ANDA | Current |
| 66336-560 | Fexofenadine Hydrochloride | Fexofenadine HCl | Dispensing Solutions, Inc. | ANDA | Current |
| 66336-561 | fexofenadine hydrochloride | fexofenadine hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |
| 68071-2176 | fexofenadine hydrochloride | fexofenadine hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3228 | Fexofenadine Hydrochloride | Fexofenadine HCl | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3228 | Fexofenadine Hydrochloride | Fexofenadine HCl | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3228 | Fexofenadine Hydrochloride | Fexofenadine HCl | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-5185 | Fexofenadine Hydrochloride | Fexofenadine HCl | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5185 | Fexofenadine Hydrochloride | Fexofenadine HCl | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68151-1452 | Fexofenadine Hydrochloride | Fexofenadine HCl | Carilion Materials Management | ANDA | Current |
| 68151-3977 | fexofenadine hydrochloride | fexofenadine hydrochloride | Carilion Materials Management | ANDA | Current |
| 68196-571 | members mark fexofenadine | fexofenadine hydrochloride | Sam's West Inc | ANDA | Current |
| 68391-571 | Berkley and Jensen Allergy Relief | fexofenadine hcl | BJWC | ANDA | Current |
| 68391-571 | Berkley and Jensen Allergy Relief | fexofenadine hcl | BJWC | ANDA | Current |
| 68391-571 | Berkley and Jensen Allergy Relief | fexofenadine hcl | BJWC | ANDA | Current |
| 68391-571 | Berkley and Jensen Allergy Relief | fexofenadine hcl | BJWC | ANDA | Current |
| 68391-571 | Berkley and Jensen Allergy Relief | fexofenadine hcl | BJWC | ANDA | Current |
| 68788-6776 | fexofenadine hydrochloride | fexofenadine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6776 | fexofenadine hydrochloride | fexofenadine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6776 | fexofenadine hydrochloride | fexofenadine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69256-571 | Harris Teeter Allergy Relief | fexofenadine hcl | Harris Teeter, LLC | ANDA | Current |
| 70000-0212 | Leader Allergy Relief | fexofenadine hcl | Cardinal Health | ANDA | Current |
| 70000-0212 | Leader Allergy Relief | fexofenadine hcl | Cardinal Health | ANDA | Current |
| 70518-1702 | fexofenadine hydrochloride | fexofenadine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1702 | fexofenadine hydrochloride | fexofenadine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1702 | fexofenadine hydrochloride | fexofenadine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1702 | fexofenadine hydrochloride | fexofenadine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70677-0079 | Sunmark Fexofenadine Hydrochloride | Fexofenadine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 70677-0079 | Sunmark Fexofenadine Hydrochloride | Fexofenadine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 70677-0079 | Sunmark Fexofenadine Hydrochloride | Fexofenadine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 70934-484 | fexofenadine hydrochloride | fexofenadine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-568 | Fexofenadine Hydrochloride | Fexofenadine HCl | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71335-0290 | Fexofenadine Hydrochloride | Fexofenadine HCl | Bryant Ranch Prepack | ANDA | Current |
| 71335-0290 | Fexofenadine Hydrochloride | Fexofenadine HCl | Bryant Ranch Prepack | ANDA | Current |
| 71335-0290 | Fexofenadine Hydrochloride | Fexofenadine HCl | Bryant Ranch Prepack | ANDA | Current |
| 71335-0721 | fexofenadine hydrochloride | fexofenadine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0721 | fexofenadine hydrochloride | fexofenadine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0721 | fexofenadine hydrochloride | fexofenadine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71610-041 | fexofenadine hydrochloride | fexofenadine hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72288-425 | basic care allergy | Fexofenadine HCl | Amazon.com Services LLC | ANDA | Current |
| 72288-425 | basic care allergy | Fexofenadine HCl | Amazon.com Services LLC | ANDA | Current |
| 72288-571 | basic care allergy | fexofenadine hcl | Amazon.com Services LLC | ANDA | Current |
| 72288-571 | basic care allergy | fexofenadine hcl | Amazon.com Services LLC | ANDA | Current |
| 80159-102 | Picnic Antihistamine | fexofenadine hcl | 30M One, Inc. | ANDA | Current |
| 80159-102 | Picnic Antihistamine | fexofenadine hcl | 30M One, Inc. | ANDA | Current |