Application 212971
- Type
- ANDA
- Sponsor
- L PERRIGO CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 002 | FEXOFENADINE HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| A212971-001 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | ||
| A212971-002 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 |
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 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A212971-001 | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2020-02-24 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A212971-002 | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2020-02-24 | bb7c543d1eb4… |
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 | Proficient Rx LP | 4a9b4b7f-0441-44d3-86c7-2542ef4b119a | 2022-12-01 | Warnings | 212971 ANDA212971 71205-739 |
| Fexofenadine Hydrochloride | FEXOFENADINE HYDROCHLORIDE | Padagis Israel Pharmaceuticals Ltd | e43b561e-d68a-47af-be93-d710f0f77505 | 2022-02-22 | Warnings | 212971 ANDA212971 45802-847 |
| allergy relief | FEXOFENADINE HYDROCHLORIDE | Publix Super Markets Inc | 76014f1e-fa48-4d64-9ce6-1eaebd0419fc | 2022-01-21 | Warnings | 212971 ANDA212971 56062-847 |
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 |
|---|---|---|---|---|---|
| 0113-0847 | good sense aller ease | fexofenadine hydrochloride | L. Perrigo Company | ANDA | Current |
| 11673-617 | up and up allergy relief | fexofenadine hydrochloride | Target Corporation | ANDA | Current |
| 36800-691 | topcare allergy relief | fexofenadine hydrochloride | Topco Associates LLC | ANDA | Current |
| 37808-847 | allergy relief | fexofenadine hydrochloride | H E B | ANDA | Current |
| 45802-847 | Fexofenadine Hydrochloride | fexofenadine hydrochloride | Padagis Israel Pharmaceuticals Ltd | ANDA | Current |
| 55301-847 | exchange select aller ease | fexofenadine hydrochloride | Army & Air Force Exchange Service | ANDA | Current |
| 55301-847 | exchange select aller ease | fexofenadine hydrochloride | Army & Air Force Exchange Service | ANDA | Current |
| 55910-609 | dg health aller ease | fexofenadine hydrochloride | Dolgencorp Inc | ANDA | Current |
| 56062-847 | allergy relief | fexofenadine hydrochloride | Publix Super Markets Inc | ANDA | Current |
| 63629-9463 | Fexofenadine Hydrochloride | fexofenadine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-9463 | Fexofenadine Hydrochloride | fexofenadine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63981-847 | kirkland signature aller fex | fexofenadine hydrochloride | Costco Wholesale Company | ANDA | Current |
| 68391-847 | berkley jensen allergy relief | fexofenadine hydrochloride | BJWC | ANDA | Current |
| 71205-739 | Fexofenadine Hydrochloride | fexofenadine hydrochloride | Proficient Rx LP | ANDA | Current |
| 72288-847 | basic care allergy | fexofenadine hydrochloride | Amazon.com Services LLC | ANDA | Current |
| 72476-847 | careone allergy relief | fexofenadine hydrochloride | Retail Business Services, LLC | ANDA | Current |
| 79481-0847 | allergy relief | fexofenadine hydrochloride | Meijer, Inc. | ANDA | Current |
| 80159-112 | picnic antihistamine | fexofenadine hydrochloride | 30M One, Inc. | ANDA | Current |