Application 206465

Type: ANDA
Sponsor: ALKEM LABS LTD

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
A206465-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-03-21
A206465-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-21
A206465-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-21
A206465-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206465-001	AB
A206465-002	AB
A206465-003	AB
A206465-004	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	A206465-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206465-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206465-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206465-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206465-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206465-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206465-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206465-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206465-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206465-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206465-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206465-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206465-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206465-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206465-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206465-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206465-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206465-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206465-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206465-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206465-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206465-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206465-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206465-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206465-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206465-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206465-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206465-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206465-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206465-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206465-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206465-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206465-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206465-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206465-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206465-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206465-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2017-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206465-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2017-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206465-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2017-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206465-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2017-03-21	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A206465-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206465-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206465-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206465-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206465-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206465-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206465-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206465-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206465-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206465-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206465-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206465-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206465-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206465-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206465-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206465-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206465-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206465-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206465-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206465-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206465-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206465-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206465-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206465-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206465-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206465-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206465-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206465-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206465-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206465-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206465-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206465-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206465-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206465-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206465-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206465-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206465-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206465-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206465-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206465-004	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 1 · 10 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	67da041b-7ad5-4309-86b3-8c30a5f9465e	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206465 application number: ANDA206465 ndc (product): 71335-2035
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	c2d9a04e-8c72-d487-e053-2a95a90a0fcd	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206465 application number: ANDA206465 ndc (product): 68071-2407
Rosuvastatin	ROSUVASTATIN	Quallent Pharmaceuticals Health LLC	0d12ae85-71bd-4818-a82d-fd068530bd87	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206465 application number: ANDA206465
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	e08b4f88-0713-1141-e053-2a95a90ae7b5	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206465 application number: ANDA206465 ndc (product): 51655-987
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Ascend Laboratories, LLC	4ccbaa83-d57a-421e-88a8-1cee42d4207b	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206465 application number: ANDA206465 ndc (product): 67877-439 ndc (product): 67877-440 ndc (product): 67877-442 ndc (product): 67877-441
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	7b2fc012-bf45-4a27-9e48-67926972918d	2023-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206465 application number: ANDA206465 ndc (product): 50090-5189
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	76bbea68-52d8-4ba9-a772-0ba75a38f2eb	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206465 application number: ANDA206465
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	0514e340-54a7-470c-8072-c8113fddf2d9	2023-04-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206465 application number: ANDA206465
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	ac89adcd-3226-4a66-8902-0f0a33be159a	2023-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206465 application number: ANDA206465 ndc (product): 50090-5188
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	3aa55393-11c9-4c31-8697-ecaad8c78857	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206465 application number: ANDA206465 ndc (product): 50090-5468

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5188	Rosuvastatin Calcium	Rosuvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-5188	Rosuvastatin Calcium	Rosuvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-5188	Rosuvastatin Calcium	Rosuvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-5188	Rosuvastatin Calcium	Rosuvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-5188	Rosuvastatin Calcium	Rosuvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-5189	Rosuvastatin Calcium	Rosuvastatin Calcium	A-S Medication Solutions	ANDA	Current
50090-5468	Rosuvastatin Calcium	Rosuvastatin Calcium	A-S Medication Solutions	ANDA	Current
51655-987	Rosuvastatin Calcium	Rosuvastatin Calcium	Northwind Pharmaceuticals	ANDA	Current
67877-439	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-439	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-439	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-439	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-439	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-440	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-440	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-440	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-440	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-440	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-441	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-441	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-441	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-441	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-441	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-442	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-442	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-442	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-442	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
67877-442	Rosuvastatin Calcium	Rosuvastatin Calcium	Ascend Laboratories, LLC	ANDA	Current
68071-2407	Rosuvastatin Calcium	Rosuvastatin Calcium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7947	Rosuvastatin Calcium	Rosuvastatin Calcium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7947	Rosuvastatin Calcium	Rosuvastatin Calcium	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-2035	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current