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 13 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	Dr. Reddy's Laboratories Limited	901550e6-22be-68c9-eb86-f85a9c9dd998	2021-06-20	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Dr. Reddy's Laboratories Limited	6ccdb6f3-22c7-5b48-46bc-ce4a4c65eb4d	2020-11-30	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	d77e155c-403d-449e-bafd-11c9bd4974dd	2020-01-01	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	bd56a76b-5570-46a7-9399-fc110d913bf9	2019-10-01	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	c0b4f1a2-0082-4150-8f2b-e7440252b675	2019-05-08	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	ed8e76a5-6b40-47fe-9018-25bfe690a4dd	2018-10-18	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Cipla USA Inc.,	18fe5990-399d-416c-852f-e14974317b8b	2018-03-13	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	b16b3805-7e60-447c-b3df-7a9392b63c99	2018-02-20	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.