Atorvastatin Calcium

Product NDC
51655-640
11-digit product format
516550640
Labeler code
51655
Product ID
51655-640_134d5370-36cc-4d6e-96ab-e2cff0247a26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA076477
Marketing category
ANDA
Marketing start
2014-04-03
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51655-640DDiscontinued by firm2026-08-17
excluded packagepackage51655-64051655-640-30DDiscontinued by firm2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51655-640-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51655-640-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51655-640-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51655-640-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51655-640-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51655-640-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51655-640-30IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51655-640-30IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51655-640-30IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51655-640-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51655-640-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51655-640-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51655-640-30IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51655-640-30IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51655-640-30IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-640-30IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-640-30IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-640-30IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-640-30IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-640-30IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-640-30IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51655-640-30EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076477-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-30
A076477-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-30
A076477-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-30
A076477-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-30

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076477-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-004AB11e350fbaab3a…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-640-302026-01-13C16284748780-19d75b9d0-ff8b-f424-e053-dadaa90a57ce1cf0ac79-eae1-4d6c-afe5-0b546d827982
51655-640-302020-01-31C16284748780-19d75b9d0-ff8b-f424-e053-dadaa90a57ce1cf0ac79-eae1-4d6c-afe5-0b546d827982

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUMACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-640ATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]1Legacy NDC20140403_1cf0ac79-eae1-4d6c-afe5-0b546d827982.zip

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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepack2e583569-499d-4f20-87ca-84e7d9868d222026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMSun Pharmaceutical Industries Inc.595ab888-6b55-4642-a32f-e8521821ed812026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.49dcc58a-9f23-045d-e063-6394a90abda62026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDIRECT RXc3b70f79-45a3-0869-e053-2a95a90a3cdb2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepackf7af3b3a-b73e-41ee-80e3-2be036672bb72024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.b1a840cf-47aa-b931-e053-2a95a90a10472024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepackbbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f2024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMProficient Rx LPd77e155c-403d-449e-bafd-11c9bd4974dd2020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477