ATORVASTATIN CALCIUM

Product NDC
35356-929
11-digit product format
353560929
Labeler code
35356
Product ID
35356-929_ecfeae02-a1b5-489d-8446-7a29da3a9a2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA090548
Marketing category
ANDA
Marketing start
2013-07-09
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct35356-929DDiscontinued by firm2026-08-10
excluded packagepackage35356-92935356-929-30DDiscontinued by firm2026-08-10
excluded packagepackage35356-92935356-929-60DDiscontinued by firm2026-08-10
excluded packagepackage35356-92935356-929-90DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-929-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-929-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage35356-929-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-929-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-929-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage35356-929-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-929-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-929-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage35356-929-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-929-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-929-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage35356-929-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-929-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-929-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage35356-929-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-929-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-929-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage35356-929-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-929-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-929-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage35356-929-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-929-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-929-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage35356-929-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-929-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-929-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage35356-929-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-929-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-929-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage35356-929-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-929-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-929-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage35356-929-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-929-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-929-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage35356-929-90557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090548-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29
A090548-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29
A090548-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29
A090548-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090548-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A090548-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A090548-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A090548-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29d06236e962d9…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090548-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090548-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090548-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090548-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090548-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090548-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090548-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090548-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090548-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090548-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090548-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090548-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090548-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090548-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090548-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090548-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090548-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090548-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090548-004AB1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35356-929-30EA - Each35356-929bd1ea5ed-95bb-4198-9f6a-baa7d7409d0b12015-10-02

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor Pharmaceuticalse74278b6-31fc-48d4-97b7-ba500e9e15fb2026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNORTHSTAR RX LLC52d8508b-aa98-cd89-5991-e2b5f982b6c62026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.303989c9-823e-4bcb-a7b3-7024fd0d3a382026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.e91c673d-c26c-4ff1-90d2-2b9d47a8d7712026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.d57720ab-9f83-4da9-a57f-0d55e00a605c2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMUnit Dose Solutions, Inc.53c06fa9-ec26-5fa6-e063-6294a90a337f2026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMCardinal Health 107, LLC75ea68e0-12e2-4e27-876f-f24f6e33a0b72026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMCardinal Health 107, LLCed57fc60-ecb2-419e-b09f-3c518dcf3d042026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMCardinal Health 107, LLC1272aada-9a5b-4397-bb65-9398927aa3252026-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548
Atorvastatin CalciumATORVASTATIN CALCIUMCardinal Health 107, LLCed0d5c17-0481-4d6b-8051-8d6e47f49ce52026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
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ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAvPAKb687ba81-cb24-bbdf-5dd9-ab0e53dd480b2026-03-24Warnings, Adverse reactionsExact identifier
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ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.4a2bad30-e7cf-c48a-e063-6294a90a5f472026-03-20Warnings, Adverse reactionsExact identifier
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ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.09c6c750-ae05-459f-83e8-4a9e4fd852122026-03-18Warnings, Adverse reactionsExact identifier
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ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNorthwind Health Company, LLCf32c8a4f-dee9-86a0-e053-2995a90a33882026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
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ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNorthwind Health Company, LLCf76b9e48-3ef7-e15a-e053-6394a90aed582026-01-01Warnings, Adverse reactionsExact identifier
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ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNorthwind Health Company, LLC0e10adb3-8d3a-412f-ae56-d9b9bed4641f2026-01-01Warnings, Adverse reactionsExact identifier
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ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNorthwind Health Company, LLC0c5823ce-ed5c-356c-e063-6394a90aa15d2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
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ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQPharma, Inc.f7cc5704-2131-4bcb-9ff0-33a79a8167bd2025-12-05Warnings, Adverse reactionsExact identifier
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ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQPharma, Inc.d8a72abf-1d43-47e1-88e8-c3c5cc4ba1632025-12-03Warnings, Adverse reactionsExact identifier
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ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNCS HealthCare of KY, LLC dba Vangard Labs7353f9ef-6f79-4522-886a-7a8ae4eb867e2025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090548
application number: ANDA090548