Application 206381

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

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 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	TE codes	Approval date
A206381-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24
A206381-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24
A206381-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24
A206381-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206381-001	AB
A206381-002	AB
A206381-003	AB
A206381-004	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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 116 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206381-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206381-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206381-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206381-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206381-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206381-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206381-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206381-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206381-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206381-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206381-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206381-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206381-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206381-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206381-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206381-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206381-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206381-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206381-004	AB	1	`d8e5a09893c0…`

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin	ROSUVASTATIN	Preferred Pharmaceuticals Inc.	88fd44de-f2c4-4541-a859-bb9553da9674	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	a2ac073e-4d9a-4b0a-8698-a06d73dc6962	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	4cbafae0-c316-4f28-8c95-b831cab9a0eb	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Coupler LLC	46173656-d889-ec14-e063-6294a90aae81	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	771d3591-ecca-43de-a0f3-c72adb8543f5	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Preferred Pharmaceuticals Inc.	26d14bab-ee7c-49fe-9fb0-8426a589b599	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	81910817-f976-4936-ae31-d211083d249b	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	3153ba21-6314-4d1c-a8f1-9ae7a99c2a1a	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	adf5df0d-a2e8-4c75-b8fd-15351f4223e9	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	f201a404-9170-4684-a988-0c0aedcd2ddb	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	REMEDYREPACK INC.	6ebaefa9-2c71-4777-8730-83cf5ae737cc	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Preferred Pharmaceuticals Inc.	d91dd29a-bb29-4193-a849-840f8696f658	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	REMEDYREPACK INC.	a370a6c2-b5cd-4aa0-b072-a5a8017a2d5b	2025-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	REMEDYREPACK INC.	b8b29392-85fa-417b-bd10-10ab0d07381f	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	3982830d-3cda-e636-e063-6394a90a1eb1	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	REMEDYREPACK INC.	ab8f6264-cf12-4523-92f1-2bd60b3da442	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	NuCare Pharmaceuticals, Inc.	351ee6c1-3e31-3f87-e063-6394a90a47c7	2025-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Golden State Medical Supply, Inc.	0f02c184-49f3-8fa6-e063-6394a90a5092	2025-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	ScieGen Pharmaceuticals, Inc.	ee4933c5-0d97-494d-ac0f-2083e0100836	2025-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381 ndc (product): 50228-119 ndc (product): 50228-116 ndc (product): 50228-118 ndc (product): 50228-117
Rosuvastatin	ROSUVASTATIN	A-S Medication Solutions	b7f943f4-35da-4aa7-a4fc-810b914748bf	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50228-116	Rosuvastatin	Rosuvastatin	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-116	Rosuvastatin	Rosuvastatin	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-116	Rosuvastatin	Rosuvastatin	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-117	Rosuvastatin	Rosuvastatin	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-117	Rosuvastatin	Rosuvastatin	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-117	Rosuvastatin	Rosuvastatin	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-118	Rosuvastatin	Rosuvastatin	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-118	Rosuvastatin	Rosuvastatin	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-118	Rosuvastatin	Rosuvastatin	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-119	Rosuvastatin	Rosuvastatin	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-119	Rosuvastatin	Rosuvastatin	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-119	Rosuvastatin	Rosuvastatin	ScieGen Pharmaceuticals, Inc.	ANDA	Current