Application 213072

Type: NDA
Sponsor: ALTHERA LIFE SCIENCES, LLC.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROSZET	ROSUVASTATIN CALCIUM; EZETIMIBE	TABLET; ORAL	5MG/10MG	Yes	No
002	ROSZET	ROSUVASTATIN CALCIUM; EZETIMIBE	TABLET; ORAL	10MG/10MG	Yes	No
003	ROSZET	ROSUVASTATIN CALCIUM; EZETIMIBE	TABLET;ORAL	20MG/10MG	Yes	No
004	ROSZET	ROSUVASTATIN CALCIUM; EZETIMIBE	TABLET; ORAL	40MG/10MG	Yes	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	Approval date
N213072-001	ROSZET	EZETIMIBE; ROSUVASTATIN CALCIUM	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23
N213072-002	ROSZET	EZETIMIBE; ROSUVASTATIN CALCIUM	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23
N213072-003	ROSZET	EZETIMIBE; ROSUVASTATIN CALCIUM	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23
N213072-004	ROSZET	EZETIMIBE; ROSUVASTATIN CALCIUM	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213072-001	10376470	2033-05-01	U-3095	Drug product	2021-03-29
N213072-001	9763885	2033-05-01	U-3095	Drug product	2021-03-29
N213072-002	10376470	2033-05-01	U-3095	Drug product	2021-03-29
N213072-002	9763885	2033-05-01	U-3095	Drug product	2021-03-29
N213072-003	10376470	2033-05-01	U-3095	Drug product	2021-03-29
N213072-003	9763885	2033-05-01	U-3095	Drug product	2021-03-29
N213072-004	10376470	2033-05-01	U-3095	Drug product	2021-03-29
N213072-004	9763885	2033-05-01	U-3095	Drug product	2021-03-29

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 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD	2021-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213072-001	ROSZET	10MG;EQ 5MG BASE	TABLET / ORAL	RLD	2021-03-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213072-002	ROSZET	10MG;EQ 10MG BASE	TABLET / ORAL	RLD	2021-03-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213072-003	ROSZET	10MG;EQ 20MG BASE	TABLET / ORAL	RLD	2021-03-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213072-004	ROSZET	10MG;EQ 40MG BASE	TABLET / ORAL	RLD, RS	2021-03-23	`4b0b4de00fa7…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 296 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N213072-001	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213072-001	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213072-002	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213072-002	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213072-003	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213072-003	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213072-004	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N213072-004	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213072-001	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213072-001	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213072-002	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213072-002	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213072-003	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213072-003	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213072-004	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213072-004	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213072-001	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213072-001	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213072-002	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213072-002	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213072-003	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213072-003	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213072-004	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213072-004	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213072-001	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-001	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-002	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-002	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-003	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-003	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-004	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213072-004	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-001	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-001	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-002	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-002	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-003	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-003	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-004	10376470	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213072-004	9763885	2033-05-01	U-3095	Drug product	2021-03-29	`31067a03dcf5…`

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70661-001	ROSZET	(rosuvastatin and ezetimibe)	Althera Pharmaceuticals LLC	NDA	Current
70661-001	ROSZET	rosuvastatin and ezetimibe	Althera Pharmaceuticals LLC	NDA	Current
70661-001	ROSZET	rosuvastatin and ezetimibe	Althera Pharmaceuticals LLC	NDA	Current
70661-002	ROSZET	(rosuvastatin and ezetimibe)	Althera Pharmaceuticals LLC	NDA	Current
70661-002	ROSZET	(rosuvastatin and ezetimibe)	Althera Pharmaceuticals LLC	NDA	Current
70661-002	ROSZET	(rosuvastatin and ezetimibe)	Althera Pharmaceuticals LLC	NDA	Current
70661-003	ROSZET	(rosuvastatin and ezetimibe)	Althera Pharmaceuticals LLC	NDA	Current
70661-003	ROSZET	(rosuvastatin and ezetimibe)	Althera Pharmaceuticals LLC	NDA	Current
70661-003	ROSZET	(rosuvastatin and ezetimibe)	Althera Pharmaceuticals LLC	NDA	Current
70661-004	ROSZET	(rosuvastatin and ezetimibe)	Althera Pharmaceuticals LLC	NDA	Current
70661-004	ROSZET	(rosuvastatin and ezetimibe)	Althera Pharmaceuticals LLC	NDA	Current
70661-004	ROSZET	(rosuvastatin and ezetimibe)	Althera Pharmaceuticals LLC	NDA	Current
82120-125	ROSUVASTATIN AND EZETIMIBE	rosuvastatin and ezetimibe	SCOV3 LLC	NDA AUTHORIZED GENERIC	Current
82120-126	ROSUVASTATIN AND EZETIMIBE	rosuvastatin and ezetimibe	SCOV3 LLC	NDA AUTHORIZED GENERIC	Current
82120-127	ROSUVASTATIN AND EZETIMIBE	rosuvastatin and ezetimibe	SCOV3 LLC	NDA AUTHORIZED GENERIC	Current
82120-128	ROSUVASTATIN AND EZETIMIBE	rosuvastatin and ezetimibe	SCOV3 LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79497	SUPPL	2024-08-29
79488	SUPPL	2024-08-27
69080	ORIG	2021-10-25
66877	ORIG	2021-03-25
66861	ORIG	2021-03-24