Application 090548

Type: ANDA
Sponsor: APOTEX INC

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 1.

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	TE codes	Approval date
A090548-001	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29
A090548-002	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29
A090548-003	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29
A090548-004	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090548-001	AB
A090548-002	AB
A090548-003	AB
A090548-004	AB

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090548-001	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET / ORAL	AB	2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090548-002	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET / ORAL	AB	2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090548-003	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET / ORAL	AB	2012-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090548-004	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET / ORAL	AB	2012-05-29	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090548-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090548-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090548-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090548-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090548-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090548-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090548-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090548-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090548-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090548-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090548-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090548-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090548-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090548-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090548-004	AB	1	`d06236e962d9…`

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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	52d8508b-aa98-cd89-5991-e2b5f982b6c6	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548 ndc (product): 16714-175 ndc (product): 16714-176 ndc (product): 16714-173 ndc (product): 16714-174
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	303989c9-823e-4bcb-a7b3-7024fd0d3a38	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	e91c673d-c26c-4ff1-90d2-2b9d47a8d771	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	REMEDYREPACK INC.	d57720ab-9f83-4da9-a57f-0d55e00a605c	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Unit Dose Solutions, Inc.	53c06fa9-ec26-5fa6-e063-6294a90a337f	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	75ea68e0-12e2-4e27-876f-f24f6e33a0b7	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	ed57fc60-ecb2-419e-b09f-3c518dcf3d04	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	1272aada-9a5b-4397-bb65-9398927aa325	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Cardinal Health 107, LLC	ed0d5c17-0481-4d6b-8051-8d6e47f49ce5	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	AvPAK	b687ba81-cb24-bbdf-5dd9-ab0e53dd480b	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NuCare Pharmaceuticals, Inc.	4a2bad30-e7cf-c48a-e063-6294a90a5f47	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	09c6c750-ae05-459f-83e8-4a9e4fd85212	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548 ndc (product): 43063-474
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	f32c8a4f-dee9-86a0-e053-2995a90a3388	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	f76b9e48-3ef7-e15a-e053-6394a90aed58	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	0e10adb3-8d3a-412f-ae56-d9b9bed4641f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Northwind Health Company, LLC	0c5823ce-ed5c-356c-e063-6394a90aa15d	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	QPharma, Inc.	f7cc5704-2131-4bcb-9ff0-33a79a8167bd	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548 ndc (product): 42708-013 ndc (product): 42708-014
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	QPharma, Inc.	d8a72abf-1d43-47e1-88e8-c3c5cc4ba163	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548 ndc (product): 42708-108
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	7353f9ef-6f79-4522-886a-7a8ae4eb867e	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548 ndc (product): 0615-8009 ndc (product): 0615-8007
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	e74278b6-31fc-48d4-97b7-ba500e9e15fb	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090548 application number: ANDA090548 ndc (product): 0904-6292 ndc (product): 0904-6293

NDC Listings For This Application#

NDC listings for this application page 1 of 5 · 381 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-7128	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Liberty Pharmaceuticals, Inc.	ANDA	Current
0615-8006	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8006	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8006	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, Inc	ANDA	Current
0615-8007	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8007	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8007	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8007	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8008	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8008	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8009	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8009	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8009	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8009	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-6290	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6290	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6290	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6290	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6290	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6291	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6291	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6291	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6291	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6291	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6292	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6292	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6292	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6292	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6292	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6293	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6293	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6293	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6293	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
0904-6293	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Major Pharmaceuticals	ANDA	Current
10544-874	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Blenheim Pharmacal, Inc.	ANDA	Current
16714-173	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	ANDA	Current
16714-173	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	ANDA	Current
16714-173	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	ANDA	Current
16714-174	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	ANDA	Current
16714-174	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	ANDA	Current
16714-174	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	ANDA	Current
16714-175	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	ANDA	Current
16714-175	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	ANDA	Current
16714-175	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	ANDA	Current
16714-176	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	ANDA	Current
16714-176	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	ANDA	Current
16714-176	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	NORTHSTAR RX LLC	ANDA	Current
33261-959	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Aidarex Pharmaceuticals LLC	ANDA	Current
35356-894	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-929	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
42708-013	Atorvastatin Calcium	Atorvastatin Calcium	QPharma Inc	ANDA	Current
42708-013	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	QPharma Inc	ANDA	Current
42708-013	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	QPharma Inc	ANDA	Current
42708-014	Atorvastatin Calcium	Atorvastatin Calcium	QPharma Inc	ANDA	Current
42708-014	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	QPharma Inc	ANDA	Current
42708-014	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	QPharma Inc	ANDA	Current
42708-108	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	QPharma Inc	ANDA	Current
42708-108	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	QPharma Inc	ANDA	Current
42708-108	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	QPharma Inc	ANDA	Current
43063-453	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-453	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-453	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-453	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-453	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-453	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-453	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-453	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-453	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-474	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-474	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-474	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-474	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-474	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-474	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-474	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-474	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-496	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-496	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-496	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-496	ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	PD-Rx Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22711	ORIG	2015-03-09