Application 019778

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRINZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	TABLET;ORAL	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	PRINZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	TABLET;ORAL	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	PRINZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	TABLET;ORAL	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019778-001	PRINZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-02-16
N019778-002	PRINZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-02-16
N019778-003	PRINZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-18

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 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019778-002	PRINZIDE	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019778-003	PRINZIDE	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019778-001	PRINZIDE	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-02-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019778-002	PRINZIDE	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-02-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019778-003	PRINZIDE	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019778-001	PRINZIDE	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-02-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019778-002	PRINZIDE	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-02-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019778-003	PRINZIDE	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019778-001	PRINZIDE	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-02-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019778-002	PRINZIDE	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-02-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019778-003	PRINZIDE	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019778-001	PRINZIDE	12.5MG;20MG	TABLET / ORAL	RLD	1989-02-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019778-002	PRINZIDE	25MG;20MG	TABLET / ORAL	RLD	1989-02-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019778-003	PRINZIDE	12.5MG;10MG	TABLET / ORAL	RLD	1993-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019778-001	PRINZIDE	12.5MG;20MG	TABLET / ORAL	RLD	1989-02-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019778-002	PRINZIDE	25MG;20MG	TABLET / ORAL	RLD	1989-02-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019778-003	PRINZIDE	12.5MG;10MG	TABLET / ORAL	RLD	1993-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019778-001	PRINZIDE	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019778-002	PRINZIDE	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019778-003	PRINZIDE	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019778-001	PRINZIDE	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-02-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019778-002	PRINZIDE	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-02-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019778-003	PRINZIDE	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019778-001	PRINZIDE	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019778-002	PRINZIDE	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019778-003	PRINZIDE	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019778-001	PRINZIDE	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019778-002	PRINZIDE	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019778-003	PRINZIDE	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019778-001	PRINZIDE	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019778-002	PRINZIDE	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019778-003	PRINZIDE	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019778-001	PRINZIDE	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019778-002	PRINZIDE	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019778-003	PRINZIDE	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019778-001	PRINZIDE	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019778-002	PRINZIDE	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019778-003	PRINZIDE	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019778-001	PRINZIDE	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019778-002	PRINZIDE	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-02-16	`3f01610625f2…`

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
11711	SUPPL	2013-03-01
19211	SUPPL	2013-02-28
33948	SUPPL	2012-06-11
19210	SUPPL	2012-06-08
33946	SUPPL	2011-11-21
19208	SUPPL	2011-11-21
19209	SUPPL	2011-08-31
33947	SUPPL	2011-08-30
19207	SUPPL	2011-06-17
11710	SUPPL	2011-02-11
1611	SUPPL	2008-10-14
1610	SUPPL	2008-10-14
1609	SUPPL	2007-02-12
19206	SUPPL	2006-10-23
19205	SUPPL	2006-06-20
1608	SUPPL	2005-10-11
41023	SUPPL	2004-04-21
19204	SUPPL	2004-03-03
19203	SUPPL	2002-11-08
1607	SUPPL	2002-07-02
41022	SUPPL	2001-06-22
33945	SUPPL	1998-10-28
20349	SUPPL	1998-10-28
19202	SUPPL	1998-10-28