Application 079167

Type: ANDA
Sponsor: WATSON LABS INC

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
A079167-001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-04-29
A079167-002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-04-29
A079167-003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-04-29
A079167-004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079167-001	AB
A079167-002	AB
A079167-003	AB
A079167-004	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	A079167-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079167-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079167-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079167-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079167-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079167-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079167-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079167-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079167-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079167-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079167-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079167-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079167-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079167-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079167-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079167-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079167-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079167-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079167-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079167-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079167-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079167-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079167-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079167-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079167-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079167-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079167-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079167-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079167-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079167-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079167-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079167-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079167-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079167-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079167-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079167-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079167-001	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET / ORAL	AB	2016-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079167-002	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2016-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079167-003	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2016-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079167-004	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2016-04-29	`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	A079167-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079167-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079167-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079167-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079167-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079167-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079167-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079167-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079167-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079167-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079167-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079167-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079167-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079167-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079167-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079167-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079167-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079167-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079167-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079167-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079167-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079167-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079167-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079167-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079167-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079167-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079167-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079167-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079167-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079167-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079167-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079167-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079167-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079167-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079167-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079167-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079167-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079167-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079167-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079167-004	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 2 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	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 calcium	ROSUVASTATIN CALCIUM	REMEDYREPACK INC.	94245f53-2892-4209-8c94-c32c87d5b106	2026-03-10	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
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6602	Rosuvastatin Calcium	Rosuvastatin calcium	Major Pharmaceuticals	ANDA	Current
0904-6603	Rosuvastatin Calcium	Rosuvastatin calcium	Major Pharmaceuticals	ANDA	Current
0904-6604	Rosuvastatin Calcium	Rosuvastatin calcium	Major Pharmaceuticals	ANDA	Current
0904-6605	Rosuvastatin Calcium	Rosuvastatin calcium	Major Pharmaceuticals	ANDA	Current
50090-2805	Rosuvastatin Calcium	Rosuvastatin calcium	A-S Medication Solutions	ANDA	Current
70518-0167	Rosuvastatin Calcium	Rosuvastatin calcium	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39567	ORIG	2016-05-03
31419	ORIG	2016-05-03