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 10 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	Bryant Ranch Prepack	6c1e9bf3-ef52-4053-933d-5a5f7405e642	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	46df076d-4e98-6faa-e054-00144ff8d46c	2024-07-16	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	9c435528-4c44-44c6-bb10-049a72533c2f	2024-07-16	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	9e014adf-251e-126e-e053-2995a90a05bf	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	a0835fa8-bd55-33bd-e053-2a95a90a96b1	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	a0732bc4-702d-f566-e053-2a95a90a1d69	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	95729689-8055-45ae-e053-2995a90a919f	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	8d5b85cf-d8a0-e4d7-e053-2a95a90aad67	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	8ee8b455-625c-ead6-e053-2a95a90aed29	2024-06-18	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc,	1adc3c12-1a78-33a0-e063-6294a90a486a	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	862f9f27-c645-2d2e-e053-2991aa0a96b9	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	862f58d1-476c-2c90-e053-2991aa0ab821	2024-06-14	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	Novadoz Pharmaceuticals LLC	bc448f40-421c-490f-8c39-fa8135507973	2024-06-13	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM, FILM COATED	Bryant Ranch Prepack	32b40825-6b0b-4025-86f5-b4e453efea92	2024-06-13	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Teva Pharmaceuticals USA, Inc.	86841382-4229-4e03-958e-3ac22639efd4	2024-06-01	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	bbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f	2024-05-30	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	a33838d7-4e5e-4079-9d3d-00c2048cf776	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cadila Pharmaceuticals Limited	51730b09-24e8-41c8-9fec-813f8a64b433	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals,Inc.	fa2d8d38-dbd0-43fd-e053-6294a90a4e94	2024-05-13	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	Lifestar Pharma LLC	de8f2c55-44d2-4e01-b7f2-dfb24f1f8760	2024-04-30	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.