Application 078773

Type: ANDA
Sponsor: TEVA 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
A078773-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2012-05-29
A078773-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2012-05-29
A078773-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2012-05-29
A078773-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2012-05-29

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	A078773-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2012-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078773-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2012-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078773-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2012-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078773-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2012-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078773-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078773-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078773-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2012-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078773-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2012-05-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078773-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078773-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078773-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078773-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2012-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078773-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078773-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078773-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078773-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2012-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078773-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078773-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078773-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078773-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2012-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078773-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078773-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078773-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078773-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2012-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078773-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078773-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078773-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078773-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2012-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078773-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078773-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078773-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078773-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2012-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078773-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078773-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078773-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078773-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2012-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078773-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078773-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078773-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078773-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	2012-05-29	`5bbf6a4d5a75…`

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 6 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	af38f580-ce13-436a-a7e3-853c5ac8e540	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: atorvastatin calcium generic name: ATORVASTATIN CALCIUM
atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	befeea30-acf5-425d-bdea-5c79a9ebfad8	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: atorvastatin calcium generic name: ATORVASTATIN CALCIUM
atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	54f93ed0-64ef-46bb-aab6-a8dd5dc4c035	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: atorvastatin calcium generic name: ATORVASTATIN CALCIUM
atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	9271942d-0151-4434-80de-bbccd8868c9c	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: atorvastatin calcium generic name: ATORVASTATIN CALCIUM
atorvastatin calcium	ATORVASTATIN CALCIUM	A-S Medication Solutions	b8a7c3b3-f87e-4112-9998-578b2613da47	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	f1f3e4e0-5407-4831-9885-3a37e72356c0	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	4509aa67-06d4-41d1-80b6-c9bd8ad0bf07	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Accord Healthcare Inc.	4e06b20d-cc5d-46eb-991b-5972248de3af	2025-10-06	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	46eeb12f-7e38-4828-b7d1-26b6155bc64a	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	e959b07b-3e6c-44cc-9a6d-c6689d393e4c	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM, FILM COATED	Preferred Pharmaceuticals Inc.	7fc58ce3-f069-409b-b36f-bb23ce21fb6f	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	1e9151aa-053f-a17d-e063-6294a90afea5	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	Coupler LLC	3eee2ddb-851e-15ad-e063-6394a90a173a	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM, FILM COATED	NuCare Pharmaceuticals, Inc.	3ef3b6e3-83dc-e06a-e063-6394a90a152c	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium
Atorvastatin calcium	ATORVASTATIN CALCIUM	NorthStar RxLLC	85fbaf22-017b-4163-b33e-c6594994859b	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
Atorvastatin calcium	ATORVASTATIN CALCIUM	Bryant Ranch Prepack	00afce9b-48c9-487a-a738-e359c005c707	2025-08-28	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Quallent Pharmaceuticals Health LLC	5b94b6f4-6f64-4551-abcb-8e845fb13813	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM
Atorvastatin Calcium	ATORVASTATIN CALCIUM, FILM COATED	Rising Pharma Holdings, Inc.	73cefb0b-1747-4fe0-b252-377f4ed94c6f	2025-08-18	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium
Atorvastatin Calcium	ATORVASTATIN CALCIUM, FILM COATED	NuCare Pharmaceuticals, Inc.	3bde7950-3d25-a86e-e063-6394a90ae623	2025-08-08	Warnings, Adverse reactions	Name fallback brand name: Atorvastatin Calcium
Atorvastatin calcium	ATORVASTATIN CALCIUM	Preferred Pharmaceuticals Inc.	4ff0d618-cde4-49ae-8bcb-98dafc3ecdba	2025-08-08	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
22627	ORIG	2015-03-09
31387	ORIG	2011-12-01