Home Applications 019221 Application 019221
Type NDA
Sponsor BAUSCH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VASERETIC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 10MG;25MG Yes Yes 003 VASERETIC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE TABLET;ORAL 5MG;12.5MG Yes 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 N019221-001 VASERETIC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 N019221-003 VASERETIC ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12
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 3 · 84 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 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019221-001 VASERETIC 10MG;25MG TABLET / ORAL AB RLD, RS 1986-10-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019221-003 VASERETIC 5MG;12.5MG TABLET / ORAL AB RLD 1995-07-12 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 Vaseretic ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Bausch Health US, LLC bf3007e2-8fcc-48de-8fd5-55e95033d62f 2020-08-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019221 application number: NDA019221 ndc (product): 0187-0146
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0187-0146 Vaseretic enalapril maleate and hydrochlorothiazide Bausch Health US LLC NDA Current 0187-0146 Vaseretic enalapril maleate and hydrochlorothiazide Bausch Health US LLC NDA Current 0187-0146 Vaseretic enalapril maleate and hydrochlorothiazide Bausch Health US LLC NDA Current 0187-0146 Vaseretic enalapril maleate and hydrochlorothiazide Bausch Health Americas, Inc. NDA Current 0187-0146 Vaseretic enalapril maleate and hydrochlorothiazide Bausch Health US LLC NDA Current 0187-0146 Vaseretic enalapril maleate and hydrochlorothiazide Valeant Pharmaceuticals North America LLC NDA Current