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 | CVS Pharmacy, Inc | 840e017d-0142-4d0e-a80e-327ac44bc0c5 | 2024-04-24 | Warnings | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Walgreen Co. | 3829826b-e48f-4e26-869f-6b9e4ee0a840 | 2024-04-24 | Warnings | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Mylan Institutional LLC | 7faaedb3-227b-408d-b772-6b326638b00e | 2024-04-12 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Par Health USA, LLC | 3ae08e26-223b-4971-b2f1-f1e183a3f930 | 2024-04-11 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| naloxone hydrochloride | NALOXONE HYDROCHLORIDE | Lifestar Pharma LLC | ef647e2a-84e7-4e3e-942a-b6fc250141b6 | 2024-03-04 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c72a60fb-196d-3f02-e053-2995a90ad906 | 2024-02-22 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 94ff1857-06da-7986-e053-2a95a90afb18 | 2024-02-19 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c90e2d85-ed94-2c00-e053-2a95a90ad2a0 | 2024-01-30 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Actavis Pharma, Inc. | 49350f7e-d613-40a8-8941-a2ec30eafdf3 | 2024-01-30 | Warnings | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | e65e03c1-9a66-b30b-e053-2995a90aeb73 | 2024-01-27 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | HF Acquisition Co. LLC, DBA HealthFirst | 74fc593e-ed47-efae-e053-2991aa0a5997 | 2024-01-25 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Teva Pharmaceuticals, Inc. | 3a73ee4b-c2a4-496f-be90-9f78c8046062 | 2024-01-01 | Warnings | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | A-S Medication Solutions | 46f27d04-d4d2-4ef1-9cc5-4d58f4056f06 | 2023-12-27 | Warnings | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | A-S Medication Solutions | 0b3b5214-6f91-4bba-82d6-d57b16845df5 | 2023-10-01 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NARCAN | NALOXONE HYDROCHLORIDE | A-S Medication Solutions | 139c30b9-5600-48f5-8610-0cacd2782398 | 2023-09-28 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Hospira, Inc. | b598c237-032d-4bb5-0e92-50eabd863dac | 2023-06-04 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | A-S Medication Solutions | 3d2dcee4-7510-477b-95a8-9b2afb773984 | 2023-05-23 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 958577c3-d2c4-26ad-e053-2a95a90ad73a | 2023-05-15 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 9e53f169-4a6e-6102-e053-2995a90ab3dc | 2023-05-09 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
| NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | ada6856c-5293-fc2f-e053-2995a90a8ec6 | 2023-05-03 | Warnings, Adverse reactions | NALOXONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.