Application 020729

Type
NDA
Sponsor
UCB INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UNIRETICHYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDETABLET;ORAL12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
002UNIRETICHYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDETABLET;ORAL25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
003UNIRETICHYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDETABLET;ORAL12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020729-001UNIRETICHYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27
N020729-002UNIRETICHYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27
N020729-003UNIRETICHYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-14

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020729-002UNIRETIC25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020729-003UNIRETIC12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020729-002UNIRETIC25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020729-003UNIRETIC12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020729-002UNIRETIC25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020729-003UNIRETIC12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020729-002UNIRETIC25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020729-003UNIRETIC12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020729-002UNIRETIC25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020729-003UNIRETIC12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020729-002UNIRETIC25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020729-003UNIRETIC12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020729-002UNIRETIC25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020729-003UNIRETIC12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020729-002UNIRETIC25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020729-003UNIRETIC12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020729-002UNIRETIC25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020729-003UNIRETIC12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N020729-002UNIRETIC25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N020729-003UNIRETIC12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020729-002UNIRETIC25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020729-003UNIRETIC12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020729-002UNIRETIC25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020729-003UNIRETIC12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020729-002UNIRETIC25MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020729-003UNIRETIC12.5MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL2002-02-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020729-001UNIRETIC12.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORAL1997-06-278072bd15b7f6…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
25652SUPPL2012-09-17
35246SUPPL2012-09-14
35245SUPPL2012-01-23
3220SUPPL2012-01-23
13305SUPPL2011-09-02
25651SUPPL2011-08-26
35244SUPPL2011-05-23
35243SUPPL2010-01-20
25650SUPPL2010-01-15
20885SUPPL2007-09-26
25649SUPPL2003-11-25
3219SUPPL2002-02-14