Application 079170

Type: ANDA
Sponsor: AUROBINDO PHARMA 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
A079170-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19
A079170-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19
A079170-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19
A079170-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079170-001	AB
A079170-002	AB
A079170-003	AB
A079170-004	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	A079170-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079170-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079170-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079170-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079170-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079170-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079170-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079170-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079170-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079170-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079170-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079170-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079170-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079170-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079170-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079170-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079170-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079170-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079170-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079170-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079170-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079170-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079170-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079170-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079170-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079170-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079170-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079170-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079170-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079170-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079170-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079170-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079170-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079170-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079170-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079170-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079170-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079170-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079170-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079170-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-07-19	`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	A079170-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079170-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079170-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079170-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079170-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079170-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079170-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079170-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079170-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079170-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079170-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079170-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079170-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079170-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079170-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079170-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079170-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079170-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079170-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079170-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079170-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079170-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079170-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079170-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079170-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079170-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079170-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079170-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079170-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079170-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079170-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079170-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079170-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079170-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079170-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079170-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079170-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079170-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079170-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079170-004	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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Aurobindo Pharma Limited	47924917-bbd5-45de-96cb-c7ff9754da97	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170 ndc (product): 65862-294 ndc (product): 65862-296 ndc (product): 65862-295 ndc (product): 65862-293
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	275d4288-064d-d1bd-e063-6294a90a28e1	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	f2b71718-c054-3e05-e053-2995a90a52bf	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	American Health Packaging	b7491a1a-570e-40ea-b65b-f956c9e284a6	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	85ed9283-4e16-41bf-95ed-01b62640fd2c	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	3dd06868-6b71-4ddd-bc9c-57e1cf6656a5	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170 ndc (product): 63629-7157
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	3debe076-4af2-456f-9c27-8ff81d6aec1b	2025-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	98bf4f79-2d42-4b69-966b-2275189a4d4d	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	216d8a80-9bc6-493a-90d3-a00926b49572	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	7a969720-7994-43a1-97c0-5e7842ae2be4	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Rising Pharma Holdings, Inc.	5c992d3d-d754-48b6-a267-1451208352ed	2024-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	0ec87d67-4fe0-4f5a-aa6b-114042ebc249	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	d147d4b2-5c2a-44d2-abb6-e77715f2b0f5	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	8030f0bc-fb11-4c85-8058-ed6482689d1a	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	d84f596d-8b99-419c-9a02-4b5e26aeaea8	2024-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	6c061ef9-1dcd-4efd-b0ce-6f3ab91b1bc6	2023-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	86fde296-d1c5-4fe8-9050-77c074914f63	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	a9478b12-89d2-42a4-a310-707a87ef43d7	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170 ndc (product): 71205-078
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	3066f572-e3db-4bf8-b9ee-bd32d9ed8c13	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079170 application number: ANDA079170 ndc (product): 63187-872

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 152 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63187-872	Rosuvastatin Calcium	Rosuvastatin Calcium	Proficient Rx LP	ANDA	Current
63187-872	Rosuvastatin Calcium	Rosuvastatin Calcium	Proficient Rx LP	ANDA	Current
63629-7057	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
63629-7057	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
63629-7057	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
63629-7057	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
63629-7146	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
63629-7157	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
63629-7157	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
63629-7157	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
63629-7157	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
65862-293	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-293	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-293	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-293	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-293	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-293	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-294	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-294	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-294	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-294	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-294	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-294	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-295	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-295	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-295	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-295	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-295	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-295	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-296	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-296	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-296	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-296	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-296	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
65862-296	Rosuvastatin Calcium	Rosuvastatin Calcium	Aurobindo Pharma Limited	ANDA	Current
68071-2634	Rosuvastatin Calcium	Rosuvastatin Calcium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2637	Rosuvastatin Calcium	Rosuvastatin Calcium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5258	Rosuvastatin Calcium	Rosuvastatin Calcium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5258	Rosuvastatin Calcium	Rosuvastatin Calcium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6823	Rosuvastatin Calcium	Rosuvastatin Calcium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8135	Rosuvastatin Calcium	Rosuvastatin Calcium	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0002	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-0002	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-0002	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-0002	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-0987	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-0987	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-0987	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-0987	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-0987	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-1444	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-1444	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-1632	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-1632	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-1632	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-1712	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-1712	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-2141	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70518-2141	Rosuvastatin Calcium	Rosuvastatin Calcium	REMEDYREPACK INC.	ANDA	Current
70934-834	Rosuvastatin Calcium	Rosuvastatin Calcium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-078	Rosuvastatin Calcium	Rosuvastatin Calcium	Proficient Rx LP	ANDA	Current
71205-078	Rosuvastatin Calcium	Rosuvastatin Calcium	Proficient Rx LP	ANDA	Current
71205-078	Rosuvastatin Calcium	Rosuvastatin Calcium	Proficient Rx LP	ANDA	Current
71205-078	Rosuvastatin Calcium	Rosuvastatin Calcium	Proficient Rx LP	ANDA	Current
71335-0068	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
71335-0068	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
71335-0959	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
71335-0959	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
71335-0959	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
71335-0959	Rosuvastatin Calcium	Rosuvastatin Calcium	Bryant Ranch Prepack	ANDA	Current
71610-196	Rosuvastatin Calcium	Rosuvastatin Calcium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-216	Rosuvastatin Calcium	Rosuvastatin Calcium	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9232	ORIG	2016-07-20
31421	ORIG	2010-05-17