Application 217992
- Type
- ANDA
- Sponsor
- AMNEAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | SPRAY, METERED;NASAL | 4MG/SPRAY | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217992-001 | NALOXONE HYDROCHLORIDE | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 |
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 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | 8072bd15b7f6… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217992-001 | NALOXONE HYDROCHLORIDE | 4MG/SPRAY | SPRAY, METERED / NASAL | 2024-04-23 | 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 | AvKARE | 1766a7f1-d301-945f-e063-6294a90ac6f4 | 2026-01-14 | Warnings | 217992 ANDA217992 |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | 8091a73d-9ecd-4578-a57b-5d85a2c5a16a | 2025-12-09 | Warnings | 217992 ANDA217992 |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | CVS Pharmacy, Inc | 840e017d-0142-4d0e-a80e-327ac44bc0c5 | 2024-04-24 | Warnings | 217992 ANDA217992 |
| Naloxone Hydrochloride | NALOXONE HYDROCHLORIDE | Walgreen Co. | 3829826b-e48f-4e26-869f-6b9e4ee0a840 | 2024-04-24 | Warnings | 217992 ANDA217992 |
| Naloxone Hydrochloride | NALOXONE | Amneal Pharmaceuticals NY LLC | 8779a073-dc6e-410a-9959-fd370f0079f9 | 2024-04-19 | Warnings | 217992 ANDA217992 |