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 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	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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079166-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	2016-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079166-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2016-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079166-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2016-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079166-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2016-07-19	`d8e5a09893c0…`

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 1 of 7 · 133 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	d9b83920-26ae-462a-ac10-33fd1ed7738f	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	23cc6801-f296-494e-b737-6d7c6df092c3	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Redpharm Drug	57d1fb5b-1b85-7dd9-e063-6394a90a3fb1	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Redpharm Drug	57d226e7-30f4-cecb-e063-6394a90a692f	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	HEC Pharm USA Inc.	568a782b-1621-5e59-e063-6294a90a7fef	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Zhejiang Yongtai Pharmaceutical Co., Ltd.	40c2900e-4659-49ce-ba4b-5df529b3c53b	2026-07-25	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	0c919fc0-a3d7-4afb-968b-4ef0e447001c	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	11fad602-16c2-4c1f-bdf1-867d95f063ca	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Cadila Pharmaceuticals Limited	6802a946-a29c-4d41-997b-3c078ed8e74d	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NorthStar Rx, LLC	c622757d-7370-438b-8c2d-ef444a4f31dd	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Aurobindo Pharma Limited	47924917-bbd5-45de-96cb-c7ff9754da97	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Torrent Pharmaceuticals Limited	8c2d481f-53f2-4cf6-bd28-7d92323785cd	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Umedica Laboratories USA Inc.	989dffcf-0254-439d-9f3f-3b0e9d32de0a	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Shandong New Time Pharmaceutical Co., Ltd.	ae865404-ecf4-41a8-b40b-62f887c220f2	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	67da041b-7ad5-4309-86b3-8c30a5f9465e	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Glenmark Pharmaceutials Inc., USA	392657a9-955c-42c2-814c-1890ece45afa	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	Bryant Ranch Prepack	bf40166a-4f73-47ff-938b-2bdbf7f000e4	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: ROSUVASTATIN CALCIUM generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	9d5f8ff6-c622-4101-805d-70bdc888b27e	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	76568df9-1a56-4e23-ac84-28f3b72cc242	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	5da61cc3-93f3-4d95-ab39-55821484a3bd	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM

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