Application 208478

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE	No	No
002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 20MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208478-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL			2020-06-23
A208478-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL			2020-06-23

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 2 · 78 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	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208478-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2020-06-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208478-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2020-06-23	`bb7c543d1eb4…`

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 9 of 13 · 248 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Direct_Rx	23ac06e0-556c-c640-e063-6394a90a931d	2025-01-14	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	9168df23-4260-46be-9556-8b037af0ea28	2025-01-01	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	694a6a7f-9d46-46b0-9329-ad8c2bd5e403	2024-12-09	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	a20bac35-a3d7-4e97-95c2-2502107d61c2	2024-11-13	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	4b2d0de1-50f0-4356-aa79-88696be8ac3d	2024-11-01	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	76e8e69c-590f-4f74-82e1-199d8d14fa80	2024-11-01	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	5a132b72-5318-43ab-881d-a2e51bd20bdc	2024-11-01	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	1fb2d51e-360c-40a3-8072-f22893890a51	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	cbeb2aa0-24a2-430f-b456-34a4e63e1817	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	ace2c37e-b525-4fe7-8316-9bd3fa4a092c	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	57b070d1-217a-413b-9350-e2387c5c282a	2024-10-23	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	9d11f845-8e56-4251-8a1f-8f4b3843ea62	2024-10-23	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	251828ae-7519-35c2-e063-6394a90a71ea	2024-10-22	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	25015637-c825-487c-ac33-c5ac46a4732f	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NorthStar RxLLC	c1ba8fd9-aa40-466c-81bd-a87b364e9a1a	2024-09-27	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	f7af3b3a-b73e-41ee-80e3-2be036672bb7	2024-08-22	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	40e6b63f-0a20-404a-8915-2f698877a96b	2024-08-19	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	47709fe3-88d3-4d2e-b9db-a06dc1c2c7d4	2024-07-22	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	b1a840cf-47aa-b931-e053-2a95a90a1047	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	b490414a-35e7-fded-e053-2a95a90aca8d	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.