Application 206434

Type: ANDA
Sponsor: ACCORD HLTHCARE

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
A206434-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31
A206434-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31
A206434-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31
A206434-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206434-001	AB
A206434-002	AB
A206434-003	AB
A206434-004	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	A206434-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206434-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206434-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206434-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206434-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206434-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206434-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206434-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206434-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206434-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206434-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206434-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206434-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206434-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206434-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206434-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206434-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206434-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206434-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206434-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206434-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206434-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206434-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206434-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206434-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206434-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206434-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206434-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206434-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206434-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206434-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206434-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206434-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206434-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206434-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206434-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206434-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206434-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206434-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206434-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-10-31	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A206434-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206434-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206434-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206434-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206434-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206434-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206434-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206434-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206434-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206434-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206434-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206434-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206434-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206434-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206434-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206434-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206434-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206434-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206434-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206434-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206434-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206434-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206434-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206434-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206434-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206434-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206434-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206434-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206434-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206434-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206434-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206434-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206434-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206434-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206434-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206434-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206434-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206434-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206434-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206434-004	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 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	bf40166a-4f73-47ff-938b-2bdbf7f000e4	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206434 application number: ANDA206434 ndc (product): 71335-0302
Rosuvastatin	ROSUVASTATIN	Accord Healthcare Inc.	3ffe0294-3997-2755-e054-00144ff8d46c	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206434 application number: ANDA206434
Rosuvastatin	ROSUVASTATIN	Bryant Ranch Prepack	0ad5b7de-e97d-4989-91e4-edae73543896	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206434 application number: ANDA206434 ndc (product): 71335-0749
Rosuvastatin	ROSUVASTATIN	Bryant Ranch Prepack	aa7443b0-9f75-47fc-a5ce-c7245444419c	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206434 application number: ANDA206434 ndc (product): 71335-0606
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Proficient Rx LP	eaf91ddd-0d4f-4c77-9dba-a2a3abb86ea4	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206434 application number: ANDA206434 ndc (product): 71205-355
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	aa64d28f-0926-4ff2-bb28-578e5ef233eb	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206434 application number: ANDA206434
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	a1b4d50b-eda3-437c-9c80-4d854361ddc2	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206434 application number: ANDA206434
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	5a874865-3cbe-4589-9787-046feb9a2c46	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206434 application number: ANDA206434
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	a5ee9510-e691-49ec-a5cd-49e70371ee4d	2019-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206434 application number: ANDA206434 ndc (product): 71610-215
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	410a0a03-6751-4c3d-82bf-c7c6a4081fdd	2018-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206434 application number: ANDA206434 ndc (product): 71610-187
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	69dfa637-2a81-4c7e-8fef-d4b4ab4c3f25	2018-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206434 application number: ANDA206434 ndc (product): 71610-078

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 2 of 2 · 97 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71205-355	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Proficient Rx LP	ANDA	Current
71205-355	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Proficient Rx LP	ANDA	Current
71335-0302	Rosuvastatin calcium	Rosuvastatin calcium	Bryant Ranch Prepack	ANDA	Current
71335-0302	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	ANDA	Current
71335-0390	Rosuvastatin calcium	Rosuvastatin calcium	Bryant Ranch Prepack	ANDA	Current
71335-0606	Rosuvastatin calcium	Rosuvastatin calcium	Bryant Ranch Prepack	ANDA	Current
71335-0606	Rosuvastatin	Rosuvastatin	Bryant Ranch Prepack	ANDA	Current
71335-0749	Rosuvastatin calcium	Rosuvastatin calcium	Bryant Ranch Prepack	ANDA	Current
71335-0749	Rosuvastatin	Rosuvastatin	Bryant Ranch Prepack	ANDA	Current
71335-0749	Rosuvastatin calcium	Rosuvastatin calcium	Bryant Ranch Prepack	ANDA	Current
71335-1440	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	ANDA	Current
71335-1440	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
71610-078	Rosuvastatin calcium	Rosuvastatin calcium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-187	Rosuvastatin calcium	Rosuvastatin calcium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-215	Rosuvastatin calcium	Rosuvastatin calcium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
76519-1153	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	H. J. Harkins Company Inc.	ANDA	Current
76519-1153	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	H. J. Harkins Company Inc.	ANDA	Current