Application 079166

Type: ANDA
Sponsor: TEVA PHARMS USA

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	Approval date
A079166-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2016-07-19
A079166-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2016-07-19
A079166-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2016-07-19
A079166-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2016-07-19

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079166-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2016-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079166-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2016-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079166-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2016-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A079166-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2016-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079166-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079166-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079166-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2016-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079166-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2016-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079166-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079166-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079166-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2016-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079166-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2016-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079166-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2016-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079166-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2016-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079166-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2016-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079166-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2016-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079166-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2016-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079166-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2016-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079166-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2016-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079166-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2016-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079166-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2016-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079166-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2016-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079166-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2016-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079166-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2016-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079166-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2016-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079166-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2016-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079166-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2016-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079166-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2016-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079166-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2016-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079166-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2016-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079166-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2016-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079166-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2016-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079166-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2016-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079166-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2016-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079166-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2016-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079166-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2016-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079166-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2016-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079166-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2016-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079166-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2016-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079166-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2016-07-19	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A079166-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079166-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079166-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079166-004	AB	1	`ea99ee380514…`

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 3 of 7 · 130 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	da6bfffb-7b04-b522-e053-2a95a90a4736	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	f2a1008e-963c-9999-e053-2a95a90ae726	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	1d86f10c-1e47-cefc-e063-6394a90a9f2e	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	e3d92523-2dbe-930b-e053-2a95a90ac3f2	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	f2b71718-c054-3e05-e053-2995a90a52bf	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	f80c5f1e-6a36-4b76-e053-6394a90a681d	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	e08b4f88-0713-1141-e053-2a95a90ae7b5	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Ascend Laboratories, LLC	4ccbaa83-d57a-421e-88a8-1cee42d4207b	2025-12-23	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Westminster Pharmaceuticals, LLC	02797697-300a-43db-92cf-9b78f08626be	2025-11-26	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	1eb971e3-de67-46ae-a8ef-8a7d2805cfdd	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	3493b809-74b0-71b0-e063-6294a90a9a99	2025-10-07	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NorthStar RxLLC	17d71c80-fade-4735-acec-60738d26dd01	2025-08-11	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	45033c5f-4246-491a-8707-10f840ff2b6c	2025-08-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Biocon Pharma Inc	033d8c8f-bbe9-96b5-fd53-cb0ef929857a	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	4bd37cda-9928-456c-86be-aaccccf2e450	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	ebb0c5d6-d816-44fa-8422-82aa63076d55	2025-04-28	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Golden State Medical Supply, Inc.	7c3af5aa-2223-463a-e053-2a91aa0a16f9	2025-04-02	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Cranbury Pharmaceuticals, LLC	606d16fb-82e4-420d-9456-09997562b528	2025-03-27	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	85ed9283-4e16-41bf-95ed-01b62640fd2c	2025-02-19	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Quallent Pharmaceuticals Health LLC	6f978191-775e-4745-9c07-99e5be888afe	2025-02-07	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7571	Rosuvastatin Calcium	Rosuvastatin Calcium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7572	Rosuvastatin Calcium	Rosuvastatin Calcium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7573	Rosuvastatin Calcium	Rosuvastatin Calcium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42708-111	Rosuvastatin Calcium	Rosuvastatin Calcium	QPharma Inc	ANDA	Current
45865-893	Rosuvastatin Calcium	Rosuvastatin Calcium	medsource pharmaceuticals	ANDA	Current
63187-869	Rosuvastatin Calcium	Rosuvastatin Calcium	Proficient Rx LP	ANDA	Current
63187-869	Rosuvastatin Calcium	Rosuvastatin Calcium	Proficient Rx LP	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31418	ORIG	2016-07-20
9230	ORIG	2010-05-17