Home Applications 213843 Application 213843
Type ANDA
Sponsor MYLAN LABS LTD 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 42 .
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 A213843-001 NALOXONE HYDROCHLORIDE NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213843-001 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.
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 2026-08-18 06:07:40 2026-07 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213843-001 NALOXONE HYDROCHLORIDE 1MG/ML INJECTABLE / INJECTION AP 2022-06-09 a50c72e98297…
Observed Orange Book normalized TE history# 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 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67457-992 Naloxone Hydrochloride Naloxone Hydrochloride Mylan Institutional LLC ANDA Current 67457-992 Naloxone Hydrochloride Naloxone Hydrochloride Mylan Institutional LLC ANDA Current