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 | Henry Schein, Inc. | ddeebc32-9aab-4a2f-8c87-74335d17d5ef | 2025-10-28 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | ProPharma Distribution | 3f2bb95a-aeca-c0b7-e063-6394a90a627b | 2025-09-19 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | e6467385-6990-498c-8a0e-f4a40ef33cb7 | 2025-09-02 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | AMERISOURCE BERGEN | cce38c13-0d2f-49bb-94fa-6f2bbb4d5984 | 2025-08-31 | Warnings | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 3ba53405-5e72-c035-e063-6294a90ac0b1 | 2025-08-05 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Fresenius Kabi USA, LLC | 201fdedf-1736-4e52-9d7d-de14292547fd | 2025-07-31 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | ProPharma Distribution | 3856ea66-29b8-8fc2-e063-6394a90ac33a | 2025-07-18 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Eugia US LLC | 8bcf426a-b4fc-4f24-9ad0-fb26168a0b56 | 2025-05-14 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| naloxone hydrochloride | NALOXONE HYDROCHLORIDE | NorthStar RxLLC | d4c44b74-4e36-4b63-80eb-64ce99ccb39f | 2025-01-27 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Henry Schein, Inc. | d39635a4-ddb3-4d32-8211-eb84c78e9f59 | 2025-01-27 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 9bcff682-1196-7cef-e053-2a95a90aa954 | 2025-01-08 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | International Medication Systems, Limited | 236349ef-2cb5-47ca-a3a5-99534c3a4996 | 2024-12-16 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 28f3e3bc-b1be-9f06-e063-6394a90a1936 | 2024-12-10 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Asclemed USA, Inc. | 7acf3bde-f858-4fbc-8a11-6741a3d27b8e | 2024-10-29 | Warnings | NALOXONE HYDROCHLORIDE |
| naloxone hydrochloride | NALOXONE HYDROCHLORIDE | Baxter Healthcare Corporation | 48137634-91d7-41e3-b54b-e4321d69668a | 2024-10-04 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Bryant Ranch Prepack | ed549649-dcbd-41f7-a774-876906751c5a | 2024-10-03 | Warnings | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Eugia US LLC | c7fa8d4f-28a7-4ef5-aef8-cbd4328ce599 | 2024-07-06 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Eugia US LLC | 2725b9c0-5b1e-498b-9ec5-ee76a62e656a | 2024-07-06 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 1be2e38b-55ca-abea-e063-6394a90ac548 | 2024-06-27 | Warnings | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 19b0603b-241f-f439-e063-6294a90ae85f | 2024-05-30 | Warnings | NALOXONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.