Home Applications 216603 Application 216603
Type ANDA
Sponsor AMNEAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 10MG/ML No No 002 ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION 20MG/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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216603-001 ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 A216603-002 ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 50 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 2026-08-18 06:07:40 2026-07 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216603-001 ESMOLOL HYDROCHLORIDE 1GM/100ML INJECTABLE / INJECTION AP 2022-12-13 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216603-002 ESMOLOL HYDROCHLORIDE 2GM/100ML INJECTABLE / INJECTION AP 2022-12-13 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 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 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 70121-1716 Esmolol Hydrochloride Esmolol Hydrochloride in Sodium Chloride Amneal Pharmaceuticals LLC ANDA Current 70121-1717 Esmolol Hydrochloride Esmolol Hydrochloride in Sodium Chloride Amneal Pharmaceuticals LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 73137 ORIG 2023-01-10