Application 216421
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZELASTINE HYDROCHLORIDE ALLERGY | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 0.2055MG/SPRAY | No | No |
| 002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | AZELASTINE HYDROCHLORIDE | SPRAY, METERED;NASAL | 0.2055MG/SPRAY | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | ||
| A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | AZELASTINE HYDROCHLORIDE | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 |
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 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | 1e350fbaab3a… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216421-001 | AZELASTINE HYDROCHLORIDE ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216421-002 | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY | 0.2055MG/SPRAY | SPRAY, METERED / NASAL | 2024-05-29 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Azelastine Hydrochloride | AZELASTINE HYDROCHLORIDE | CVS PHARMACY, INC | 22d516d0-da22-4e3b-a4a5-135b009bc968 | 2026-05-21 | Warnings | 216421 ANDA216421 |
| Azelastine Hydrochloride | AZELASTINE HYDROCHLORIDE | Walgreens | ec268981-433f-b26b-4ff0-3a121e0a0d08 | 2026-04-16 | Warnings | 216421 ANDA216421 |
| AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE | Allegiant Health | cc7ddac6-95fa-4bc0-824d-f80e404e8d32 | 2025-05-02 | Warnings | 216421 ANDA216421 |
| AZELASTINE HYDROCHLORIDE | AZELASTINE HYDROCHLORIDE | Allegiant Health | 3e2fdb0d-c2f5-41ab-b1cd-4fae80648112 | 2025-05-02 | Warnings | 216421 ANDA216421 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78841 | ORIG | 2024-06-20 |