Application 077081
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 180MG | No | No |
| 002 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 003 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | 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 |
|---|---|---|---|---|---|---|---|
| A077081-001 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2007-04-16 | ||
| A077081-002 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2008-04-11 | ||
| A077081-003 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2008-04-11 | ||
| A077081-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2011-07-21 | ||
| A077081-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2011-07-21 | ||
| A077081-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2011-07-21 | ||
| A077081-007 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2011-07-21 | ||
| A077081-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2011-07-21 | ||
| A077081-009 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2011-07-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077081-001 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2007-04-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077081-002 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2008-04-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077081-003 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2008-04-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077081-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-07-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077081-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-07-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077081-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-07-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077081-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-07-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077081-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-07-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077081-009 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2011-07-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077081-001 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2007-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077081-002 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2008-04-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077081-003 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2008-04-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077081-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-07-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077081-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-07-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077081-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-07-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077081-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-07-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077081-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-07-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077081-009 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2011-07-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077081-001 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2007-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077081-002 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2008-04-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077081-003 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2008-04-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077081-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-07-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077081-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-07-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077081-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-07-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077081-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-07-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077081-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-07-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077081-009 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2011-07-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077081-001 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2007-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077081-002 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2008-04-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077081-003 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2008-04-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077081-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-07-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077081-005 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2011-07-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077081-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2011-07-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077081-007 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2011-07-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077081-008 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2011-07-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077081-009 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2011-07-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077081-001 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | AB | 2007-04-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077081-002 | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2008-04-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077081-003 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2008-04-11 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077081-004 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2011-07-21 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077081-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077081-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077081-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077081-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077081-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077081-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077081-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077081-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077081-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077081-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077081-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077081-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077081-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077081-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077081-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077081-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077081-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077081-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077081-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077081-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077081-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077081-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077081-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077081-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077081-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077081-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077081-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077081-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077081-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077081-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077081-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077081-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077081-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077081-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077081-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077081-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077081-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077081-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077081-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A077081-003 | AB | 1 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|
| 0378-0781 | Fexofenadine Hydrochloride | fexofenadine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0781 | Fexofenadine Hydrochloride | fexofenadine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0781 | Fexofenadine Hydrochloride | fexofenadine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0781 | Fexofenadine Hydrochloride | fexofenadine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0781 | Fexofenadine Hydrochloride | fexofenadine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0782 | Fexofenadine Hydrochloride | fexofenadine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0782 | Fexofenadine Hydrochloride | fexofenadine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0782 | Fexofenadine Hydrochloride | fexofenadine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0782 | Fexofenadine Hydrochloride | fexofenadine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0782 | Fexofenadine Hydrochloride | fexofenadine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 43353-760 | Fexofenadine Hydrochloride | fexofenadine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 51079-547 | Fexofenadine Hydrochloride | fexofenadine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-547 | Fexofenadine Hydrochloride | fexofenadine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-548 | Fexofenadine Hydrochloride | fexofenadine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-548 | Fexofenadine Hydrochloride | fexofenadine hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 70518-0746 | Fexofenadine Hydrochloride | fexofenadine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0746 | Fexofenadine Hydrochloride | fexofenadine | REMEDYREPACK INC. | ANDA | Current |