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 43.

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 · 172 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
2026-09-14 22:38:34	2026-08	A206381-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2019-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206381-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2019-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206381-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2019-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206381-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2019-04-24	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206381-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206381-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206381-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206381-004	AB	1	`84e616aacf4f…`
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…`

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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin	ROSUVASTATIN	Bryant Ranch Prepack	e7955483-fecd-4376-b177-c669f862a3ac	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Bryant Ranch Prepack	e4f6f29b-9d44-4389-9aa8-01000f94775e	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Bryant Ranch Prepack	4ba31486-c9e7-4361-b658-5464dc9ebc14	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Bryant Ranch Prepack	cc9c9664-2601-4dff-843b-1e96f6c8a70a	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	1185b112-f59d-8762-e063-6394a90a120d	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	11701a6e-9b34-4939-e063-6294a90a09c9	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381
Rosuvastatin	ROSUVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	11831846-b3ba-ba0b-e063-6394a90a4cb2	2024-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206381 application number: ANDA206381

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 · 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