Application 208969
- Type
- NDA
- Sponsor
- AMPHASTAR PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | REXTOVY | NALOXONE HYDROCHLORIDE | SPRAY, METERED;NASAL | 4MG/SPRAY | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208969-001 | REXTOVY | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N208969-001 | NP | 2026-03-07 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2023-03-07 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2023-03-07 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2023-03-07 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD | 2023-03-07 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N208969-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N208969-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | 053a50430f4f… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N208969-001 | REXTOVY | 4MG/SPRAY | SPRAY, METERED / NASAL | RLD, RS | 2023-03-07 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N208969-001 | NP | 2026-03-07 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N208969-001 | NP | 2026-03-07 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N208969-001 | NP | 2026-03-07 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N208969-001 | NP | 2026-03-07 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208969-001 | NP | 2026-03-07 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N208969-001 | NP | 2026-03-07 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208969-001 | NP | 2026-03-07 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208969-001 | NP | 2026-03-07 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208969-001 | NP | 2026-03-07 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208969-001 | NP | 2026-03-07 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208969-001 | NP | 2026-03-07 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208969-001 | NP | 2026-03-07 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N208969-001 | NP | 2026-03-07 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208969-001 | NP | 2026-03-07 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208969-001 | NP | 2026-03-07 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208969-001 | NP | 2026-03-07 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N208969-001 | NP | 2026-03-07 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N208969-001 | NP | 2026-03-07 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N208969-001 | NP | 2026-03-07 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N208969-001 | NP | 2026-03-07 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N208969-001 | NP | 2026-03-07 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N208969-001 | NP | 2026-03-07 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N208969-001 | NP | 2026-03-07 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N208969-001 | NP | 2026-03-07 | 3f0d92c62455… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N208969-001 | NP | 2026-03-07 | 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 |
|---|---|---|---|---|---|---|
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | b621239f-0bbb-7d07-e053-2a95a90a287e | 2023-04-26 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| naloxone hydrochloride | NALOXONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | fa1ca55b-f56b-0d9b-e053-6294a90a258a | 2023-04-24 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | ea4ea2fe-af48-0b3c-e053-2a95a90a0ad5 | 2023-04-24 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | f9c5efca-443a-41a0-e053-6294a90a8774 | 2023-04-20 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co. LLC, DBA HealthFirst | 74fcd243-94b3-ec77-e053-2991aa0a229c | 2022-12-09 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Proficient Rx LP | 8d529b4c-85fd-4e50-9443-9080825307bf | 2022-10-01 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Narcan | NALOXONE HYDROCHLORIDE | Proficient Rx LP | 76b5a1ce-e601-457c-ab35-43533bba4394 | 2022-08-01 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride Injection, USP, Auto-Injector | NALOXONE HYDROCHLORIDE | Kaleo, Inc. | b5463553-b775-47a3-8d10-31e01ca1ec72 | 2022-03-11 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | International Medication Systems, Limited | d2f5bfa0-933e-46d0-8b1a-9f90e6aaba54 | 2021-12-13 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| naloxone hydrochloride | NALOXONE HYDROCHLORIDE | Baxter Healthcare Corporation | d04ae2d7-01b9-405d-bb7a-bf2d876ce26a | 2021-07-02 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Mylan Institutional LLC | d96ebf2e-1051-4b5b-b1c6-2543dbbb2d04 | 2021-04-21 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Baxter Healthcare Corporation | 3d8813be-6d22-46f1-ac25-0d8a817a521c | 2020-11-25 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Mylan Institutional LLC | f0932877-1f3b-4d5e-82d2-dd6c53db4730 | 2020-08-17 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.