Home Applications 075483 Application 075483
Type ANDA
Sponsor WOCKHARDT LTD 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 42 .
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 A075483-001 ENALAPRIL MALEATE ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 A075483-002 ENALAPRIL MALEATE ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 A075483-003 ENALAPRIL MALEATE ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 A075483-004 ENALAPRIL MALEATE ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22
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 5 · 168 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 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075483-001 ENALAPRIL MALEATE 2.5MG TABLET / ORAL AB 2000-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075483-002 ENALAPRIL MALEATE 5MG TABLET / ORAL AB 2000-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075483-003 ENALAPRIL MALEATE 10MG TABLET / ORAL AB 2000-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075483-004 ENALAPRIL MALEATE 20MG TABLET / ORAL AB 2000-08-22 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 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 3 · 168 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0615-4589 ENALAPRIL MALEATE ENALAPRIL MALEATE NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-4590 ENALAPRIL MALEATE ENALAPRIL MALEATE NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-4591 ENALAPRIL MALEATE ENALAPRIL MALEATE NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-4593 ENALAPRIL MALEATE ENALAPRIL MALEATE NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0904-5502 ENALAPRIL MALEATE ENALAPRIL MALEATE Major Pharmaceuticals ANDA Current 0904-5502 ENALAPRIL MALEATE ENALAPRIL MALEATE Major Pharmaceuticals ANDA Current 0904-5609 ENALAPRIL MALEATE ENALAPRIL MALEATE Major Pharmaceuticals ANDA Current 0904-5609 ENALAPRIL MALEATE ENALAPRIL MALEATE Major Pharmaceuticals ANDA Current 0904-5610 ENALAPRIL MALEATE ENALAPRIL MALEATE Major Pharmaceuticals ANDA Current 0904-5610 ENALAPRIL MALEATE ENALAPRIL MALEATE Major Pharmaceuticals ANDA Current 0904-5611 ENALAPRIL MALEATE ENALAPRIL MALEATE Major Pharmaceuticals ANDA Current 0904-5611 ENALAPRIL MALEATE ENALAPRIL MALEATE Major Pharmaceuticals ANDA Current 10544-170 ENALAPRIL MALEATE ENALAPRIL MALEATE Blenheim Pharmacal, Inc. ANDA Current 21695-487 ENALAPRIL MALEATE ENALAPRIL MALEATE Rebel Distributors Corp ANDA Current 21695-488 ENALAPRIL MALEATE ENALAPRIL MALEATE Rebel Distributors Corp ANDA Current 21695-489 ENALAPRIL MALEATE ENALAPRIL MALEATE Rebel Distributors Corp ANDA Current 35356-869 ENALAPRIL MALEATE ENALAPRIL MALEATE Lake Erie Medical DBA Quality Care Products LLC ANDA Current 35356-869 ENALAPRIL MALEATE ENALAPRIL MALEATE Lake Erie Medical DBA Quality Care Products LLC ANDA Current 35356-871 ENALAPRIL MALEATE ENALAPRIL MALEATE Lake Erie Medical DBA Quality Care Products LLC ANDA Current 35356-871 ENALAPRIL MALEATE ENALAPRIL MALEATE Lake Erie Medical DBA Quality Care Products LLC ANDA Current 35356-871 ENALAPRIL MALEATE ENALAPRIL MALEATE Lake Erie Medical DBA Quality Care Products LLC ANDA Current 35356-871 ENALAPRIL MALEATE ENALAPRIL MALEATE Lake Erie Medical DBA Quality Care Products LLC ANDA Current 45865-404 ENALAPRIL MALEATE ENALAPRIL MALEATE Medsource Pharmaceuticals ANDA Current 50090-0689 ENALAPRIL MALEATE ENALAPRIL MALEATE A-S Medication Solutions ANDA Current 50090-0689 ENALAPRIL MALEATE ENALAPRIL MALEATE A-S Medication Solutions ANDA Current 50090-0689 ENALAPRIL MALEATE ENALAPRIL MALEATE A-S Medication Solutions ANDA Current 50090-0690 ENALAPRIL MALEATE ENALAPRIL MALEATE A-S Medication Solutions ANDA Current 50090-0690 ENALAPRIL MALEATE ENALAPRIL MALEATE A-S Medication Solutions ANDA Current 50090-0690 ENALAPRIL MALEATE ENALAPRIL MALEATE A-S Medication Solutions ANDA Current 50090-0692 ENALAPRIL MALEATE ENALAPRIL MALEATE A-S Medication Solutions ANDA Current 50090-0692 ENALAPRIL MALEATE ENALAPRIL MALEATE A-S Medication Solutions ANDA Current 50090-0692 ENALAPRIL MALEATE ENALAPRIL MALEATE A-S Medication Solutions ANDA Current 50090-0692 ENALAPRIL MALEATE ENALAPRIL MALEATE A-S Medication Solutions ANDA Current 50090-0692 ENALAPRIL MALEATE ENALAPRIL MALEATE A-S Medication Solutions ANDA Current 50090-0692 ENALAPRIL MALEATE ENALAPRIL MALEATE A-S Medication Solutions ANDA Current 50436-4353 ENALAPRIL MALEATE ENALAPRIL MALEATE Unit Dose Services ANDA Current 51138-033 Enalapril Maleate Enalapril Maleate Med Health Pharma, LLC ANDA Current 51138-034 Enalapril Maleate Enalapril Maleate Med Health Pharma, LLC ANDA Current 51138-035 Enalapril Maleate Enalapril Maleate Med Health Pharma, LLC ANDA Current 51138-036 Enalapril Maleate Enalapril Maleate Med Health Pharma, LLC ANDA Current 51655-279 ENALAPRIL MALEATE ENALAPRIL MALEATE Northwind Pharmaceuticals, LLC ANDA Current 53808-0242 ENALAPRIL MALEATE ENALAPRIL MALEATE State of Florida DOH Central Pharmacy ANDA Current 53808-0243 ENALAPRIL MALEATE ENALAPRIL MALEATE State of Florida DOH Central Pharmacy ANDA Current 53808-0244 ENALAPRIL MALEATE ENALAPRIL MALEATE State of Florida DOH Central Pharmacy ANDA Current 53808-0966 ENALAPRIL MALEATE ENALAPRIL MALEATE State of Florida DOH Central Pharmacy ANDA Current 55289-591 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, In ANDA Current 55289-591 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-591 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-591 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-591 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-591 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-694 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-694 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-694 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-694 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-694 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-984 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-984 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-984 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-984 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-984 ENALAPRIL MALEATE ENALAPRIL MALEATE PD-Rx Pharmaceuticals, Inc. ANDA Current 55648-923 ENALAPRIL MALEATE ENALAPRIL MALEATE Wockhardt Limited ANDA Current 55648-924 ENALAPRIL MALEATE ENALAPRIL MALEATE Wockhardt Limited ANDA Current 55648-925 ENALAPRIL MALEATE ENALAPRIL MALEATE Wockhardt Limited ANDA Current 55648-926 ENALAPRIL MALEATE ENALAPRIL MALEATE Wockhardt Limited ANDA Current 60760-226 ENALAPRIL MALEATE ENALAPRIL MALEATE St Marys Medical Park Pharmacy ANDA Current 60760-226 ENALAPRIL MALEATE ENALAPRIL MALEATE St Marys Medical Park Pharmacy ANDA Current 60760-226 ENALAPRIL MALEATE ENALAPRIL MALEATE St Marys Medical Park Pharmacy ANDA Current 60760-227 ENALAPRIL MALEATE ENALAPRIL MALEATE St Marys Medical Park Pharmacy ANDA Current 61919-277 ENALAPRIL MALEATE ENALAPRIL MALEATE DirectRX ANDA Current 61919-277 ENALAPRIL MALEATE ENALAPRIL MALEATE DirectRX ANDA Current 61919-277 ENALAPRIL MALEATE ENALAPRIL MALEATE DirectRX ANDA Current 61919-372 ENALAPRIL MALEATE ENALAPRIL MALEATE DIRECT RX ANDA Current 61919-372 ENALAPRIL MALEATE ENALAPRIL MALEATE DIRECT RX ANDA Current 61919-372 ENALAPRIL MALEATE ENALAPRIL MALEATE Direct_Rx ANDA Current 61919-372 ENALAPRIL MALEATE ENALAPRIL MALEATE DIRECT RX ANDA Current 61919-372 ENALAPRIL MALEATE ENALAPRIL MALEATE DIRECT RX ANDA Current 61919-690 ENALAPRIL MALEATE ENALAPRIL MALEATE DIRECT RX ANDA Current 61919-690 ENALAPRIL MALEATE ENALAPRIL MALEATE DIRECT RX ANDA Current 61919-690 ENALAPRIL MALEATE ENALAPRIL MALEATE DIRECT RX ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30909 ORIG 2000-08-22