Home Applications 216458 Application 216458
Type ANDA
Sponsor AUROBINDO PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENALAPRIL MALEATE ENALAPRIL MALEATE SOLUTION;ORAL 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 A216458-001 ENALAPRIL MALEATE ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216458-001 AB
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 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216458-001 ENALAPRIL MALEATE 1MG/ML SOLUTION / ORAL AB 2024-01-08 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.