Home Applications 214442 Application 214442
Type ANDA
Sponsor CHANGZHOU PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CAPTOPRIL CAPTOPRIL TABLET;ORAL 12.5MG No No 002 CAPTOPRIL CAPTOPRIL TABLET;ORAL 25MG No No 003 CAPTOPRIL CAPTOPRIL TABLET;ORAL 50MG No No 004 CAPTOPRIL CAPTOPRIL TABLET;ORAL 100MG 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 A214442-001 CAPTOPRIL CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 A214442-002 CAPTOPRIL CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 A214442-003 CAPTOPRIL CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 A214442-004 CAPTOPRIL CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27
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 · 96 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 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214442-001 CAPTOPRIL 12.5MG TABLET / ORAL AB 2023-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214442-002 CAPTOPRIL 25MG TABLET / ORAL AB 2023-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214442-003 CAPTOPRIL 50MG TABLET / ORAL AB 2023-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214442-004 CAPTOPRIL 100MG TABLET / ORAL AB 2023-01-27 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 96 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Captopril CAPTOPRIL AiPing Pharmaceutical, Inc. 3b789f16-b291-4012-be39-af3beec3ff9a 2026-02-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 214442 application number: ANDA214442