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LISINOPRIL	TABLET;ORAL	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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LISINOPRIL	TABLET;ORAL	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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LISINOPRIL	TABLET;ORAL	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 44.

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HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-02-16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PRINZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL	25MG;20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-02-16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HYDROCHLOROTHIAZIDE; LISINOPRIL	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1993-11-18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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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UTC	2020-11	N019778-003	PRINZIDE	12.5MG;10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1993-11-18	`c0c555d07b60…`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…`
2019-12-14 00:12 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	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	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	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	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	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	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	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	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	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	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	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	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	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`

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