Application 013402

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALDORIL 15	HYDROCHLOROTHIAZIDE; METHYLDOPA	TABLET;ORAL	15MG;250MG	No	No
002	ALDORIL 25	HYDROCHLOROTHIAZIDE; METHYLDOPA	TABLET;ORAL	25MG;250MG	No	No
003	ALDORIL D30	HYDROCHLOROTHIAZIDE; METHYLDOPA	TABLET;ORAL	30MG;500MG	No	No
004	ALDORIL D50	HYDROCHLOROTHIAZIDE; METHYLDOPA	TABLET;ORAL	50MG;500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS
N013402-001	ALDORIL 15	HYDROCHLOROTHIAZIDE; METHYLDOPA	15MG;250MG	TABLET / ORAL	Approved before 1982
N013402-002	ALDORIL 25	HYDROCHLOROTHIAZIDE; METHYLDOPA	25MG;250MG	TABLET / ORAL	Approved before 1982
N013402-003	ALDORIL D30	HYDROCHLOROTHIAZIDE; METHYLDOPA	30MG;500MG	TABLET / ORAL	Approved before 1982
N013402-004	ALDORIL D50	HYDROCHLOROTHIAZIDE; METHYLDOPA	50MG;500MG	TABLET / ORAL	Approved before 1982

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 5 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N013402-001	ALDORIL 15	15MG;250MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N013402-002	ALDORIL 25	25MG;250MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N013402-003	ALDORIL D30	30MG;500MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N013402-004	ALDORIL D50	50MG;500MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N013402-001	ALDORIL 15	15MG;250MG	TABLET / ORAL	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N013402-002	ALDORIL 25	25MG;250MG	TABLET / ORAL	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N013402-003	ALDORIL D30	30MG;500MG	TABLET / ORAL	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N013402-004	ALDORIL D50	50MG;500MG	TABLET / ORAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N013402-001	ALDORIL 15	15MG;250MG	TABLET / ORAL	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N013402-002	ALDORIL 25	25MG;250MG	TABLET / ORAL	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N013402-003	ALDORIL D30	30MG;500MG	TABLET / ORAL	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N013402-004	ALDORIL D50	50MG;500MG	TABLET / ORAL	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N013402-001	ALDORIL 15	15MG;250MG	TABLET / ORAL	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N013402-002	ALDORIL 25	25MG;250MG	TABLET / ORAL	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N013402-003	ALDORIL D30	30MG;500MG	TABLET / ORAL	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N013402-004	ALDORIL D50	50MG;500MG	TABLET / ORAL	Approved before 1982	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
362	SUPPL	2004-12-30