Home Applications 077575 Application 077575
Type ANDA
Sponsor SANDOZ 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 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 TE codes RLD / RS Approval date A077575-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 A077575-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 A077575-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 A077575-004 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.
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 Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077575-004 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 A077575-001 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 A077575-002 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 A077575-003 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 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077575-004 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 A077575-001 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 A077575-002 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 A077575-003 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 A077575-004 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 A077575-001 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 A077575-002 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 A077575-003 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 A077575-004 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 A077575-001 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 A077575-002 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 A077575-003 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 A077575-004 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 A077575-001 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 A077575-002 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 A077575-003 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 A077575-004 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 A077575-001 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 A077575-002 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 A077575-003 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 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
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 9 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 Direct_Rx 23ac06e0-556c-c640-e063-6394a90a931d 2025-01-14 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM Proficient Rx LP 9168df23-4260-46be-9556-8b037af0ea28 2025-01-01 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Bryant Ranch Prepack 694a6a7f-9d46-46b0-9329-ad8c2bd5e403 2024-12-09 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Bryant Ranch Prepack a20bac35-a3d7-4e97-95c2-2502107d61c2 2024-11-13 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Proficient Rx LP 4b2d0de1-50f0-4356-aa79-88696be8ac3d 2024-11-01 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Bryant Ranch Prepack 76e8e69c-590f-4f74-82e1-199d8d14fa80 2024-11-01 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Proficient Rx LP 5a132b72-5318-43ab-881d-a2e51bd20bdc 2024-11-01 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Bryant Ranch Prepack 1fb2d51e-360c-40a3-8072-f22893890a51 2024-10-31 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Bryant Ranch Prepack cbeb2aa0-24a2-430f-b456-34a4e63e1817 2024-10-31 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Bryant Ranch Prepack ace2c37e-b525-4fe7-8316-9bd3fa4a092c 2024-10-31 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM A-S Medication Solutions 57b070d1-217a-413b-9350-e2387c5c282a 2024-10-23 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM A-S Medication Solutions 9d11f845-8e56-4251-8a1f-8f4b3843ea62 2024-10-23 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM NuCare Pharmaceuticals, Inc. 251828ae-7519-35c2-e063-6394a90a71ea 2024-10-22 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM A-S Medication Solutions 25015637-c825-487c-ac33-c5ac46a4732f 2024-10-08 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM NorthStar RxLLC c1ba8fd9-aa40-466c-81bd-a87b364e9a1a 2024-09-27 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Bryant Ranch Prepack f7af3b3a-b73e-41ee-80e3-2be036672bb7 2024-08-22 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM NCS HealthCare of KY, LLC dba Vangard Labs 40e6b63f-0a20-404a-8915-2f698877a96b 2024-08-19 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM NCS HealthCare of KY, LLC dba Vangard Labs 47709fe3-88d3-4d2e-b9db-a06dc1c2c7d4 2024-07-22 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM NuCare Pharmaceuticals,Inc. b1a840cf-47aa-b931-e053-2a95a90a1047 2024-07-17 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM NuCare Pharmaceuticals,Inc. b490414a-35e7-fded-e053-2a95a90aca8d 2024-07-17 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0781-5381 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5381 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5381 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5381 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5381 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5382 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5382 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5382 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5382 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5382 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5384 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5384 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5384 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5384 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5384 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5388 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5388 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5388 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5388 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 0781-5388 Atorvastatin Calcium atorvastatin calcium Sandoz Inc ANDA Current 43353-959 Atorvastatin Calcium atorvastatin calcium Aphena Pharma Solutions - Tennessee, LLC ANDA Current 43353-981 Atorvastatin Calcium atorvastatin calcium Aphena Pharma Solutions - Tennessee, LLC ANDA Current 68788-6958 Atorvastatin Calcium atorvastatin calcium Preferred Pharmaceuticals Inc. ANDA Current 68788-6958 Atorvastatin Calcium atorvastatin calcium Preferred Pharmaceuticals Inc. ANDA Current 68788-6958 Atorvastatin Calcium atorvastatin calcium Preferred Pharmaceuticals Inc. ANDA Current 70882-102 Atorvastatin Calcium atorvastatin calcium Cambridge Therapeutics Technologies, LLC ANDA Current 70882-106 Atorvastatin Calcium atorvastatin calcium Cambridge Therapeutics Technologies, LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22606 ORIG 2015-03-09