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 2 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	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	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
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	82308a25-97e8-44ba-a6c4-d6e03d08cd6a	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	2984f47e-9246-46d0-842e-43c540dd12a5	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	A-S Medication Solutions	2c72feef-6742-4d8a-9515-89be4e430c4f	2026-05-18	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	QPharma, Inc.	4148e0b3-0340-9f3a-e063-6394a90afc96	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Proficient Rx LP	8bd56c80-2f98-4b6e-809e-d0e981c3dcb3	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	c2d9a04e-8c72-d487-e053-2a95a90a0fcd	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
ROSUVASTATIN	ROSUVASTATIN	DIRECT RX	99602058-4681-7cb5-e053-2995a90a099c	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: ROSUVASTATIN CALCIUM generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	be73cea2-f89a-e4c5-e053-2a95a90a9cce	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	1346ab60-808b-442b-8217-a59bb9986f03	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	275d4288-064d-d1bd-e063-6294a90a28e1	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin Calcium	ROSUVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	60d52228-f74f-46eb-85d2-e6b0cbb36092	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM
Rosuvastatin calcium	ROSUVASTATIN CALCIUM	Northwind Health Company, LLC	f80b8d59-2c22-8fff-e053-6294a90a2f9e	2026-01-01	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