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 1 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	Quallent	f00a83aa-3f1d-566d-b9bb-f396f22a27cb	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Apotex Corp.	d9adb9e4-c495-9530-e5e3-7e3b01d53e4c	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	604a011e-6c64-4895-8f6e-d28f119c4c22	2026-09-04	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	57f9b462-f08e-483c-9b64-b7e4c8d46927	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	St. Mary's Medical Park Pharmacy	2e20a00c-b373-3a8c-e063-6294a90a637b	2026-08-25	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	634ec8e3-6d83-4cb2-90a3-fc9c973b06bf	2026-08-21	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	d57720ab-9f83-4da9-a57f-0d55e00a605c	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	ScieGen Pharmaceuticals, Inc.	f2d8b5e9-6ff2-4efa-ab01-e13df29f7371	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	5b3c3043-9af6-48eb-8b10-528e58c88e48	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	51e24220-3374-4e5e-9a8d-4113002c5bed	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	b0bbab86-6789-4ffb-8f84-ee91b69fdb34	2026-08-06	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	9786388d-ac8d-4646-9fe4-b33e8fda86b2	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	09cb8375-075c-47e8-a4eb-8ac667ed849e	2026-07-31	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	aee307d6-b3fa-424f-8656-1f30ff413e95	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	e74278b6-31fc-48d4-97b7-ba500e9e15fb	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	fbd1c5da-67fb-4412-acb5-4d4c74a43654	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	Macleods Pharmaceuticals Limited	7bd0f0ec-f7a3-4403-9a1a-11f18213631f	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Direct_Rx	56a9e58f-567e-30cc-e063-6294a90a290f	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	2e583569-499d-4f20-87ca-84e7d9868d22	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	52d8508b-aa98-cd89-5991-e2b5f982b6c6	2026-07-08	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