FDA.reportPublic FDA data

Application 090096

Type
ANDA
Sponsor
CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDETABLET;ORAL12.5MG;7.5MGNoNo
002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDETABLET;ORAL12.5MG;15MGNoNo
003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDETABLET;ORAL25MG;15MGNoNo

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
A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE12.5MG;7.5MGTABLET / ORAL2008-09-25
A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE12.5MG;15MGTABLET / ORAL2008-09-25
A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE25MG;15MGTABLET / ORAL2008-09-25

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 UTC2026-02A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;15MGTABLET / ORAL2008-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL2008-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;15MGTABLET / ORAL2008-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL2008-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;15MGTABLET / ORAL2008-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL2008-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;15MGTABLET / ORAL2008-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL2008-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;15MGTABLET / ORAL2008-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL2008-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;15MGTABLET / ORAL2008-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL2008-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;15MGTABLET / ORAL2008-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL2008-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;15MGTABLET / ORAL2008-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL2008-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;15MGTABLET / ORAL2008-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL2008-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;15MGTABLET / ORAL2008-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL2008-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;15MGTABLET / ORAL2008-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL2008-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;15MGTABLET / ORAL2008-09-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL2008-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090096-002MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;15MGTABLET / ORAL2008-09-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090096-003MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE25MG;15MGTABLET / ORAL2008-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090096-001MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE12.5MG;7.5MGTABLET / ORAL2008-09-258072bd15b7f6…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23937ORIG2008-11-13