Application 210667

Type: ANDA
Sponsor: SUNSHINE LAKE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	5MG	No	No
002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	10MG	No	No
003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	20MG	No	No
004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A210667-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2020-04-01
A210667-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2020-04-01
A210667-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2020-04-01
A210667-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2020-04-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A210667-001	AB
A210667-002	AB
A210667-003	AB
A210667-004	AB

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 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210667-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2020-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210667-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210667-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210667-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2020-04-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210667-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2020-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210667-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210667-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210667-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2020-04-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210667-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2020-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210667-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210667-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210667-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2020-04-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210667-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2020-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210667-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210667-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210667-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2020-04-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210667-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2020-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210667-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210667-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210667-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2020-04-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210667-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2020-04-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210667-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-04-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210667-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-04-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210667-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2020-04-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210667-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2020-04-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210667-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-04-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210667-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-04-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210667-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2020-04-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210667-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2020-04-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210667-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-04-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210667-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-04-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210667-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2020-04-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210667-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2020-04-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210667-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-04-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210667-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-04-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210667-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2020-04-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210667-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2020-04-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210667-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-04-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210667-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-04-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210667-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2020-04-01	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A210667-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210667-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210667-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210667-004	AB	1	`c0c555d07b60…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210667-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210667-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210667-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210667-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	HEC Pharm USA Inc.	568a782b-1621-5e59-e063-6294a90a7fef	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210667 application number: ANDA210667

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
48792-7883	ROSUVASTATIN CALCIUM	Rosuvastatin calcium	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
48792-7884	ROSUVASTATIN CALCIUM	Rosuvastatin calcium	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
48792-7885	ROSUVASTATIN CALCIUM	Rosuvastatin calcium	Sunshine Lake Pharma Co., Ltd.	ANDA	Current
48792-7886	ROSUVASTATIN CALCIUM	Rosuvastatin calcium	Sunshine Lake Pharma Co., Ltd.	ANDA	Current