Home Applications 072115 Application 072115
Type ANDA
Sponsor INTL MEDICATION Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE INJECTABLE;INJECTION 1MG/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A072115-001 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072115-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION 1988-04-27 cb3db0bc1861…
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 1 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 Sportpharm LLC 3750bf77-342c-4469-8bbb-f71009aa03fa 2026-07-02 Warnings Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALXONE HYDROCHLORIDE Civica, Inc. 21d20dff-6efe-481e-a5a0-9c80ded73ca9 2026-06-30 Warnings, Adverse reactions Name fallback brand name: Naloxone Hydrochloride NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst 53ed164c-dd09-4ea4-e063-6294a90a2434 2026-06-11 Warnings, Adverse reactions Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE A-S Medication Solutions 5906381c-81f4-4635-867a-e56e4d629692 2026-06-03 Warnings, Adverse reactions Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE Hospira, Inc. 8535cc84-ad4a-4d67-8480-fb5a2e3406f8 2026-05-27 Warnings, Adverse reactions Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE Somerset Therapeutics, LLC dfa48492-d83b-48cc-9ad1-bdc0c2ac9931 2026-05-05 Warnings, Adverse reactions Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE BluePoint Laboratories 327004b0-560a-84d0-e063-6294a90aa743 2026-04-02 Warnings Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE HF Acquisition Co. LLC. DBA HealthFirst 4d66b96a-acbb-2292-e063-6294a90af788 2026-03-19 Warnings, Adverse reactions Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE Henry Schein, Inc bd65e3fe-cd7a-4855-8f55-8cc3a0921ccc 2026-03-02 Warnings, Adverse reactions Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE REMEDYREPACK INC. 68df290c-d776-4cfc-9565-332eb56c4723 2026-02-10 Warnings, Adverse reactions Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE naloxone hydrochloride NALOXONE HYDROCHLORIDE Lifestar Pharma LLC aef6719c-cd71-46ee-b7b1-1806b939bf3e 2026-02-09 Warnings, Adverse reactions Name fallback brand name: naloxone hydrochloride generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE AvKARE 1766a7f1-d301-945f-e063-6294a90ac6f4 2026-01-14 Warnings Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE RiVive NALOXONE HYDROCHLORIDE Harm Reduction Therapeutics, Inc. 1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d 2026-01-13 Warnings Name fallback generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE Sina Health Inc 2879294f-9af9-459e-e063-6394a90a0820 2026-01-12 Warnings, Adverse reactions Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE Padagis Israel Pharmaceuticals Ltd b5d40220-f194-4835-b70c-f304ecb222d5 2026-01-06 Warnings Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE BPI Labs LLC 5de44ee7-6525-4857-9a67-8882e96dbeb5 2025-12-26 Warnings, Adverse reactions Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE Naloxone Hydrochloride NALOXONE HYDROCHLORIDE Amneal Pharmaceuticals NY LLC 8091a73d-9ecd-4578-a57b-5d85a2c5a16a 2025-12-09 Warnings Name fallback brand name: Naloxone Hydrochloride generic name: NALOXONE HYDROCHLORIDE Narcan NALOXONE HYDROCHLORIDE Emergent Devices Inc. 724df050-5332-4d0a-9a5f-17bf08a547e1 2025-12-05 Warnings, Adverse reactions Name fallback generic name: NALOXONE HYDROCHLORIDE ZIMHI NALOXONE HYDROCHLORIDE ZMI Pharma Inc. 523c0909-bff6-4010-988a-53de18b7cb3f 2025-12-04 Warnings, Adverse reactions Name fallback generic name: NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE Strategic Sourcing Services LLC 577fbd57-7054-4536-86c1-d43bc99cc7b1 2025-11-19 Warnings Name fallback brand name: NALOXONE HYDROCHLORIDE generic name: NALOXONE HYDROCHLORIDE