Application 204846

Type: ANDA
Sponsor: INVAGEN PHARMS

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
003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 40MG BASE	No	No
004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 80MG 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A204846-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2017-01-09
A204846-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2017-01-09
A204846-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2017-01-09
A204846-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2017-01-09

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	A204846-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2017-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204846-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2017-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204846-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2017-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204846-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2017-01-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204846-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2017-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204846-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2017-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204846-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2017-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204846-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2017-01-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204846-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2017-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204846-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2017-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204846-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2017-01-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204846-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2017-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204846-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2017-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204846-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2017-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204846-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2017-01-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204846-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2017-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204846-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2017-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204846-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2017-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204846-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2017-01-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204846-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2017-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204846-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2017-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204846-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2017-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204846-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2017-01-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204846-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2017-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204846-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2017-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204846-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2017-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204846-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2017-01-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204846-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2017-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204846-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2017-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204846-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2017-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204846-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2017-01-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204846-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2017-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204846-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2017-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204846-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2017-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204846-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2017-01-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204846-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2017-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204846-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2017-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204846-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2017-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204846-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2017-01-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204846-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2017-01-09	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204846-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204846-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204846-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204846-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204846-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204846-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204846-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204846-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204846-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204846-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204846-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204846-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204846-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204846-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204846-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204846-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204846-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204846-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204846-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204846-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204846-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204846-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204846-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204846-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204846-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204846-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204846-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204846-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204846-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204846-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204846-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204846-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204846-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204846-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204846-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204846-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204846-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204846-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204846-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204846-004	AB	1	`c0c555d07b60…`

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 12 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	A-S Medication Solutions	d97df6ad-87ca-46ec-8de7-4a958ab3b463	2023-11-24	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	3dbeae00-89ab-48a6-9e57-8048facb2294	2023-10-25	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	ba7a8604-93bb-4b82-b160-328ed17f89f9	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	1b8c55ef-160d-42df-95d1-c008f1182e3e	2023-09-14	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	107d7aed-582d-4296-99e9-ec63c41a594c	2023-08-24	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	77675dc3-868d-42a3-a179-80372a23e0c8	2023-07-21	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	0ab0bcac-10a3-4178-9674-3730683a4183	2023-07-21	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	cbbdd932-a43b-4e88-af6d-cfe994c941b3	2023-05-19	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	01eadde8-37f3-4474-995f-22c1a65adf12	2023-04-07	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	85c38e0b-3d0b-4b04-990a-ed077a4c43e4	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	d3f27113-785c-419e-955a-d6782fade438	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	f4154300-65d4-4e31-97ad-b8d086c676e2	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	Proficient Rx LP	514fcba1-713c-4aeb-be8c-369fcf9b4ffe	2023-02-01	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	a1b22973-cb9a-473e-a240-112b3e84e97c	2022-12-01	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	44f0df8b-6069-4941-87e9-2c57c8dfddfa	2022-11-28	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	957feff4-5005-4eea-bbe2-7232be65b0eb	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	a34d3c72-ce91-47c7-86a1-f32caaed2c47	2022-10-01	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	e931003a-3a8d-48b9-b13f-e620017303f6	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Proficient Rx LP	1923c91e-c6dd-4446-aabd-70a0c6aa1a82	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Aphena Pharma Solutions - Tennessee, LLC	2b7fbe2a-1f7a-4944-b589-87ca05af7481	2022-03-02	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46855	ORIG	2017-01-17