Home Applications 213273 Application 213273
Type ANDA
Sponsor PRINSTON INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET;ORAL 2.5MG No No 002 ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET;ORAL 5MG No No 003 ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET;ORAL 10MG No No 004 ENALAPRIL MALEATE ENALAPRIL MALEATE TABLET;ORAL 20MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213273-001 ENALAPRIL MALEATE ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 A213273-002 ENALAPRIL MALEATE ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 A213273-003 ENALAPRIL MALEATE ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 A213273-004 ENALAPRIL MALEATE ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 3 · 116 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 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213273-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2022-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213273-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2022-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213273-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2022-07-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213273-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2022-07-07 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 116 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 2 of 2 · 21 matching rows.
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 43547-545 Enalapril Maleate Enalapril Maleate Solco Healthcare US, LLC ANDA Current 43547-546 Enalapril Maleate Enalapril Maleate Solco Healthcare US, LLC ANDA Current 43547-547 Enalapril Maleate Enalapril Maleate Solco Healthcare US, LLC ANDA Current 43547-548 Enalapril Maleate Enalapril Maleate Solco Healthcare US, LLC ANDA Current 60760-575 Enalapril Maleate Enalapril Maleate ST. MARY'S MEDICAL PARK PHARMACY ANDA Current 60760-688 Enalapril Maleate Enalapril Maleate St Mary's Medical Park Pharmacy ANDA Current 70518-3572 Enalapril Maleate Enalapril Maleate REMEDYREPACK INC. ANDA Current 71335-9604 Enalapril Maleate Enalapril Maleate Bryant Ranch Prepack ANDA Current