Home Applications 208872 Application 208872
Type ANDA
Sponsor AKORN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE INJECTABLE;INJECTION 0.4MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208872-001 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208872-001 AP
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.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208872-001 NALOXONE HYDROCHLORIDE 0.4MG/ML INJECTABLE / INJECTION AP 2017-03-14 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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.
Matched openFDA labels page 3 of 5 · 81 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 19b0603b-241f-f439-e063-6294a90ae85f 2024-05-30 Warnings Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE REXTOVY NALOXONE HYDROCHLORIDE International Medication Systems, Ltd. fe9735db-c57e-44a8-bffb-b87a84c2a6f3 2024-05-15 Warnings, Adverse reactions Name fallback generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE CVS Pharmacy, Inc 840e017d-0142-4d0e-a80e-327ac44bc0c5 2024-04-24 Warnings Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE Walgreen Co. 3829826b-e48f-4e26-869f-6b9e4ee0a840 2024-04-24 Warnings Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE Amneal Pharmaceuticals NY LLC 8779a073-dc6e-410a-9959-fd370f0079f9 2024-04-19 Warnings Name fallback brand name: Naloxone Hydrochloride Naloxone Hydrochloride NALOXONE HYDROCHLORIDE Mylan Institutional LLC 7faaedb3-227b-408d-b772-6b326638b00e 2024-04-12 Warnings, Adverse reactions Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE Par Health USA, LLC 3ae08e26-223b-4971-b2f1-f1e183a3f930 2024-04-11 Warnings, Adverse reactions Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALXONE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. 1bef59b9-7d51-4f19-a054-44b8eb6c6398 2024-04-10 Warnings, Adverse reactions Name fallback brand name: Naloxone Hydrochloride naloxone hydrochloride NALOXONE HYDROCHLORIDE Lifestar Pharma LLC ef647e2a-84e7-4e3e-942a-b6fc250141b6 2024-03-04 Warnings, Adverse reactions Name fallback brand name: naloxone hydrochloride generic name: NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst c72a60fb-196d-3f02-e053-2995a90ad906 2024-02-22 Warnings, Adverse reactions Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 94ff1857-06da-7986-e053-2a95a90afb18 2024-02-19 Warnings, Adverse reactions Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst c90e2d85-ed94-2c00-e053-2a95a90ad2a0 2024-01-30 Warnings, Adverse reactions Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE Actavis Pharma, Inc. 49350f7e-d613-40a8-8941-a2ec30eafdf3 2024-01-30 Warnings Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst e65e03c1-9a66-b30b-e053-2995a90aeb73 2024-01-27 Warnings, Adverse reactions Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE HF Acquisition Co. LLC, DBA HealthFirst 74fc593e-ed47-efae-e053-2991aa0a5997 2024-01-25 Warnings, Adverse reactions Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE Teva Pharmaceuticals, Inc. 3a73ee4b-c2a4-496f-be90-9f78c8046062 2024-01-01 Warnings Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE A-S Medication Solutions 46f27d04-d4d2-4ef1-9cc5-4d58f4056f06 2023-12-27 Warnings Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE Somerset Therapeutics, LLC b59ee3cc-9604-4abc-81be-897e2f42aa67 2023-12-19 Warnings, Adverse reactions Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE NASAL A-S Medication Solutions 4517afa1-4b17-4a15-b91b-65b18bd0558f 2023-11-24 Warnings, Adverse reactions Name fallback brand name: Naloxone Hydrochloride NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE A-S Medication Solutions 0b3b5214-6f91-4bba-82d6-d57b16845df5 2023-10-01 Warnings, Adverse reactions Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17478-042 Naloxone Hydrochloride Naloxone Hydrochloride Akorn, Inc. ANDA Current 17478-042 Naloxone Hydrochloride Naloxone Hydrochloride Akorn, Inc. ANDA Current 17478-042 Naloxone Hydrochloride Naloxone Hydrochloride Akorn, Inc. ANDA Current 17478-042 Naloxone Hydrochloride Naloxone Hydrochloride Akorn ANDA Current 17478-042 Naloxone Hydrochloride Naloxone Hydrochloride Akorn, Inc. ANDA Current 17478-042 Naloxone Hydrochloride Naloxone Hydrochloride Akorn ANDA Current 17478-042 Naloxone Hydrochloride Naloxone Hydrochloride Akorn, Inc. ANDA Current 17478-042 Naloxone Hydrochloride Naloxone Hydrochloride Akorn, Inc. ANDA Current