Application 202039
- Type
- ANDA
- Sponsor
- AUROLIFE PHARMA LLC
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 |
|---|---|---|---|---|---|---|---|
| A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2014-11-19 | ||
| A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2014-11-19 | ||
| A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2014-11-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2020-11-12 02:37 UTC | 2020-11 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202039-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2014-11-19 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202039-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2014-11-19 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202039-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2014-11-19 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Fexofenadine Hydrochloride | FEXOFENADINE HYDROCHLORIDE | Aurohealth LLC | 5413d84e-f945-4920-8981-f62978f21d67 | 2026-08-06 | Warnings | 202039 ANDA202039 |
| Fexofenadine Hydrochloride | FEXOFENADINE HYDROCHLORIDE | Aurohealth LLC | 683cb2ea-c913-48f4-8adc-2888da3b655e | 2026-08-06 | Warnings | 202039 ANDA202039 |
| Fexofenadine Hydrochloride | FEXOFENADINE HYDROCHLORIDE | Aurohealth LLC | eb8e67dc-e2df-4c35-bfd7-12af67e1354a | 2026-08-06 | Warnings | 202039 ANDA202039 |
| Fexofenadine hydrochloride | FEXOFENADINE HYDROCHLORIDE | 7-eleven | d5914c05-e8db-4c79-82d0-a279d1304118 | 2019-06-20 | Warnings | 202039 ANDA202039 10202-229 |
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 |
|---|---|---|---|---|---|
| 0363-0095 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Walgreen CO | ANDA | Current |
| 0363-0095 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Walgreen CO | ANDA | Current |
| 0363-0097 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Walgreen CO | ANDA | Current |
| 0363-0097 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Walgreen CO | ANDA | Current |
| 10202-229 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | 7-eleven | ANDA | Current |
| 13107-066 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-067 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 42291-296 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-297 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-297 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-297 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | AvKARE | ANDA | Current |
| 46122-387 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Amerisource Bergen | ANDA | Current |
| 46122-387 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Amerisource Bergen | ANDA | Current |
| 49035-995 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Wal-Mart Stores, Inc | ANDA | Current |
| 49035-995 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Wal-Mart Stores, Inc | ANDA | Current |
| 50268-315 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | AvPAK | ANDA | Current |
| 50268-316 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | AvPAK | ANDA | Current |
| 50268-317 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | AvPAK | ANDA | Current |
| 53217-363 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53943-021 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Discount Drug Mart | ANDA | Current |
| 53943-021 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Discount Drug Mart | ANDA | Current |
| 54257-001 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Magno-Humphries Labs, Inc. | ANDA | Current |
| 54257-001 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Magno-Humphries Labs, Inc. | ANDA | Current |
| 55315-355 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Freds | ANDA | Current |
| 55315-355 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Fred's | ANDA | Current |
| 58602-710 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-710 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-711 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-711 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Aurohealth LLC | ANDA | Current |
| 60000-409 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Ahold U.S.A., Inc | ANDA | Current |
| 60000-409 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Ahold U.S.A., Inc | ANDA | Current |
| 62011-0314 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | MCKESSON | ANDA | Current |
| 62011-0314 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Healthmart | ANDA | Current |
| 62011-0315 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | MCKESSON | ANDA | Current |
| 62011-0315 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Healthmart | ANDA | Current |
| 68071-1896 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-1896 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68196-976 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Sam's West Inc | ANDA | Current |
| 68196-976 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Sam's West Inc | ANDA | Current |
| 68788-6848 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6848 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6848 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1218 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1218 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70677-0007 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Sunmark | ANDA | Current |
| 70677-0007 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | MCKESSON | ANDA | Current |
| 70677-0008 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Sunmark | ANDA | Current |
| 70677-0008 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | MCKESSON | ANDA | Current |
| 71335-0483 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0483 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71610-292 | Fexofenadine hydrochloride | Fexofenadine hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |