Application 201373
- Type
- NDA
- Sponsor
- SANOFI AVENTIS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | SUSPENSION;ORAL | 30MG/5ML | Yes | Yes |
| 002 | CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | SUSPENSION;ORAL | 30MG/5ML | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N201373-001 | CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | |
| N201373-002 | CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | |
| N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML | SUSPENSION / ORAL | RLD | 2011-01-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML | SUSPENSION / ORAL | RLD | 2011-01-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML | SUSPENSION / ORAL | RLD | 2011-01-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N201373-001 | CHILDREN'S ALLEGRA ALLERGY | 30MG/5ML | SUSPENSION / ORAL | RLD, RS | 2011-01-24 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N201373-002 | CHILDREN'S ALLEGRA HIVES | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SUSPENSION / ORAL | RLD | 2011-01-24 | 782e0a99824c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N201373-002 | 8933097 | 2032-08-16 | Drug product | 2015-02-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N201373-001 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N201373-002 | 8933097 | 2030-08-02 | Drug product | 2015-02-19 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Childrens Allegra Hives | FEXOFENADINE HCL | Chattem, Inc. | ff50d9cd-d849-43e8-b32a-4dcde798d3eb | 2026-05-01 | Warnings | 201373 NDA201373 |
| Childrens Allegra Allergy | FEXOFENADINE HYDROCHLORIDE | Chattem, Inc. | e2bd23c7-dfba-463a-adbe-2183970da740 | 2026-01-13 | Warnings | 201373 NDA201373 41167-4244 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 41167-4244 | Childrens Allegra Allergy | Fexofenadine Hydrochloride | Chattem, Inc. | NDA | Current |
| 41167-4244 | Childrens Allegra Allergy | Fexofenadine Hydrochloride | Chattem, Inc. | NDA | Current |
| 41167-4244 | Childrens Allegra Allergy | Fexofenadine Hydrochloride | Chattem, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73069 | SUPPL | 2023-01-03 |
| 73060 | SUPPL | 2022-12-28 |
| 72956 | SUPPL | 2022-12-20 |
| 72929 | SUPPL | 2022-12-20 |
| 68015 | SUPPL | 2021-07-06 |
| 68012 | SUPPL | 2021-07-06 |
| 65972 | SUPPL | 2021-01-25 |
| 65130 | SUPPL | 2020-11-03 |
| 9892 | SUPPL | 2016-06-21 |
| 19016 | SUPPL | 2016-06-17 |
| 40069 | ORIG | 2013-11-26 |
| 40070 | SUPPL | 2013-10-02 |
| 32110 | SUPPL | 2013-04-30 |
| 9891 | SUPPL | 2012-08-27 |
| 9890 | SUPPL | 2012-02-27 |
| 24392 | ORIG | 2011-10-07 |
| 22851 | ORIG | 2011-10-07 |
| 9889 | ORIG | 2011-02-02 |