Application 217634

Type: ANDA
Sponsor: STRIDES PHARMA

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
A217634-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-12-21
A217634-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-12-21
A217634-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-12-21
A217634-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-12-21

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 · 76 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	A217634-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217634-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217634-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217634-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-12-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217634-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217634-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217634-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217634-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-12-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217634-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217634-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217634-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217634-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217634-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217634-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217634-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217634-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217634-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217634-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217634-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217634-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217634-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217634-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217634-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217634-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217634-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217634-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217634-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217634-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217634-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217634-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217634-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217634-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217634-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217634-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217634-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217634-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217634-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2023-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217634-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2023-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217634-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2023-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217634-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2023-12-21	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217634-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217634-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217634-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217634-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217634-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217634-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217634-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217634-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217634-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217634-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217634-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217634-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217634-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217634-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217634-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A217634-004	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217634-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217634-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217634-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217634-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217634-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217634-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217634-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A217634-004	AB	1	`1c564ffb4f44…`

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 7 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	Teva Pharmaceuticals, Inc.	d3497ad6-b549-4144-b57f-b2088ad80b09	2025-08-01	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Camber Pharmaceuticals, Inc.	25c8f92f-9cb6-482b-82e1-16ad7c94e7b3	2025-07-28	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Mylan Institutional Inc.	7c1083b9-7a20-475d-ba12-4f5d0b53e601	2025-07-18	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	395dbb88-5889-c91c-e063-6394a90a8daf	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM, FILM COATED	Bryant Ranch Prepack	9c58c4cd-fe1c-4db7-832c-874766e4da21	2025-06-25	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium
Atorvastatin Calcium	ATORVASTATIN CALCIUM, FILM COATED	NuCare Pharmaceuticals,Inc.	3778125d-b3d9-2853-e063-6394a90aa863	2025-06-13	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	258d8737-0b80-7d80-e063-6394a90adc8e	2025-06-10	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	ac98cfd7-fd4c-4fe1-91f3-50a0e232364f	2025-06-10	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	2f84fd12-3e13-47b0-a628-d22a7c4ac3c0	2025-06-10	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
atorvastatin calcium	ATORVASTATIN CALCIUM	Zydus Pharmaceuticals USA Inc.	55ad4a90-d177-4cce-b7ec-cb75067f6c14	2025-05-30	Warnings, Adverse reactions	Name fallback brand name: atorvastatin calcium generic name: ATORVASTATIN CALCIUM
atorvastatin calcium	ATORVASTATIN CALCIUM	Zydus Lifesciences Limited	06028adf-fcb5-452c-ba67-ee53bc65c519	2025-05-30		Name fallback brand name: atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Asclemed USA, Inc.	60d51f39-8086-4434-affe-88ab8ca0c7e5	2025-05-15	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM, FILM COATED	Bryant Ranch Prepack	b8fa04f5-0d56-49ca-bb01-f0dd3b472164	2025-05-14	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Ascend Laboratories, LLC	67e60880-091a-4df7-8696-6e6c42a490e2	2025-04-29	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Direct_rx	1ade00fd-5eb4-f67a-e063-6294a90a9112	2025-04-25	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	766690b2-9784-4496-9cf3-d5584ae605de	2025-04-10	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	510426cd-63fa-4ead-81d9-0b2f4e3c1052	2025-04-10	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	9fb1a276-8253-49f0-930e-6e158d643500	2025-04-09	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	A-S Medication Solutions	fff3e5db-d15f-4eb0-b9ed-7961b4e078e4	2025-04-09	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM, FILM COATED	Bryant Ranch Prepack	17f779f2-48ac-4719-bf37-0ee162f91144	2025-04-03	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium

Reported adverse events (FAERS/openFDA)#

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