Application 213872
- Type
- NDA
- Sponsor
- BAYER HEALTHCARE LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ASTEPRO ALLERGY | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 205.5MCG/SPRAY | Yes | No |
| 002 | CHILDREN?S ASTEPRO ALLERGY | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 205.5MCG/SPRAY | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N213872-001 | ASTEPRO ALLERGY | AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | |
| N213872-002 | CHILDREN'S ASTEPRO ALLERGY | AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N213872-001 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | |
| N213872-002 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N213872-001 | ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N213872-002 | CHILDREN'S ASTEPRO ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2021-06-17 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N213872-001 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | N213872-002 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N213872-001 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213872-002 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N213872-001 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213872-002 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213872-001 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213872-002 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213872-001 | 8518919 | 2025-11-22 | U-3166 | 2021-07-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213872-001 | 9919050 | 2025-11-22 | Drug product | 2021-07-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213872-001 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213872-002 | 8518919 | 2025-11-22 | U-3166 | 2021-07-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213872-002 | 9919050 | 2025-11-22 | Drug product | 2021-07-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213872-002 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213872-001 | 8518919 | 2025-11-22 | U-3166 | 2021-07-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213872-001 | 9919050 | 2025-11-22 | Drug product | 2021-07-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213872-001 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213872-002 | 8518919 | 2025-11-22 | U-3166 | 2021-07-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213872-002 | 9919050 | 2025-11-22 | Drug product | 2021-07-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213872-002 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213872-001 | 8518919 | 2025-11-22 | U-3166 | 2021-07-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213872-001 | 9919050 | 2025-11-22 | Drug product | 2021-07-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213872-001 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213872-002 | 8518919 | 2025-11-22 | U-3166 | 2021-07-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213872-002 | 9919050 | 2025-11-22 | Drug product | 2021-07-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213872-002 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213872-001 | 8518919 | 2025-11-22 | U-3166 | 2021-07-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213872-001 | 9919050 | 2025-11-22 | Drug product | 2021-07-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213872-001 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213872-002 | 8518919 | 2025-11-22 | U-3166 | 2021-07-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213872-002 | 9919050 | 2025-11-22 | Drug product | 2021-07-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213872-002 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213872-001 | 8518919 | 2025-11-22 | U-3166 | 2021-07-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213872-001 | 9919050 | 2025-11-22 | Drug product | 2021-07-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213872-001 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213872-002 | 8518919 | 2025-11-22 | U-3166 | 2021-07-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213872-002 | 9919050 | 2025-11-22 | Drug product | 2021-07-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213872-002 | 8071073 | 2028-06-04 | Drug product | 2021-07-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213872-001 | 8518919 | 2025-11-22 | U-3166 | 2021-07-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213872-001 | 9919050 | 2025-11-22 | Drug product | 2021-07-08 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| Children Astepro Allergy | AZELASTINE HCL | Bayer HealthCare LLC. | e26f9f67-4098-6d2e-e053-2995a90a8598 | 2025-12-04 | Warnings | 213872 NDA213872 0280-0066 |
| Astepro Allergy | AZELASTINE HCL | Bayer HealthCare LLC. | e0640846-19a6-7f79-e053-2995a90a8176 | 2025-12-04 | Warnings | 213872 NDA213872 0280-0065 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.