Application 200153

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIPTRUZET	ATORVASTATIN CALCIUM; EZETIMIBE	TABLET;ORAL	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	LIPTRUZET	ATORVASTATIN CALCIUM; EZETIMIBE	TABLET;ORAL	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	LIPTRUZET	ATORVASTATIN CALCIUM; EZETIMIBE	TABLET;ORAL	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	LIPTRUZET	ATORVASTATIN CALCIUM; EZETIMIBE	TABLET;ORAL	EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 42.

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	Approval date
N200153-001	LIPTRUZET	ATORVASTATIN CALCIUM; EZETIMIBE	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03
N200153-002	LIPTRUZET	ATORVASTATIN CALCIUM; EZETIMIBE	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03
N200153-003	LIPTRUZET	ATORVASTATIN CALCIUM; EZETIMIBE	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03
N200153-004	LIPTRUZET	ATORVASTATIN CALCIUM; EZETIMIBE	EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N200153-001	LIPTRUZET	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200153-002	LIPTRUZET	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200153-003	LIPTRUZET	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200153-004	LIPTRUZET	EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200153-001	LIPTRUZET	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200153-002	LIPTRUZET	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200153-003	LIPTRUZET	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200153-004	LIPTRUZET	EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200153-001	LIPTRUZET	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200153-002	LIPTRUZET	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200153-003	LIPTRUZET	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200153-004	LIPTRUZET	EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200153-001	LIPTRUZET	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200153-002	LIPTRUZET	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200153-003	LIPTRUZET	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200153-004	LIPTRUZET	EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200153-001	LIPTRUZET	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200153-002	LIPTRUZET	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200153-003	LIPTRUZET	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200153-004	LIPTRUZET	EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200153-001	LIPTRUZET	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200153-002	LIPTRUZET	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200153-003	LIPTRUZET	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200153-004	LIPTRUZET	EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200153-001	LIPTRUZET	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200153-002	LIPTRUZET	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200153-003	LIPTRUZET	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200153-004	LIPTRUZET	EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200153-001	LIPTRUZET	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200153-002	LIPTRUZET	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200153-003	LIPTRUZET	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200153-004	LIPTRUZET	EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200153-001	LIPTRUZET	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200153-002	LIPTRUZET	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200153-003	LIPTRUZET	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200153-004	LIPTRUZET	EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200153-001	LIPTRUZET	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200153-002	LIPTRUZET	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200153-003	LIPTRUZET	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200153-004	LIPTRUZET	EQ 80MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-05-03	`d8e5a09893c0…`

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80051	SUPPL	2024-10-30
80050	SUPPL	2024-10-30
80049	SUPPL	2024-10-30
80046	SUPPL	2024-10-29
80045	SUPPL	2024-10-29
80044	SUPPL	2024-10-29
64718	SUPPL	2020-09-29
64705	SUPPL	2020-09-28
49894	SUPPL	2017-09-29
49880	SUPPL	2017-09-29
49280	SUPPL	2017-08-08
49271	SUPPL	2017-08-08
32008	SUPPL	2014-05-20
40004	SUPPL	2014-05-19
44819	ORIG	2013-10-03
43341	ORIG	2013-10-03
18946	ORIG	2013-05-09
9796	ORIG	2013-05-07

Application 200153

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

Documents#