Home Applications 214969 Application 214969
Type ANDA
Sponsor AUGUST 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 A214969-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-09-02 A214969-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2021-09-02 A214969-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2021-09-02 A214969-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2021-09-02
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 4 · 140 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 A214969-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-09-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214969-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2021-09-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214969-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2021-09-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214969-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2021-09-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214969-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214969-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2021-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214969-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2021-09-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214969-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2021-09-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214969-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214969-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2021-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214969-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2021-09-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214969-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2021-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214969-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214969-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2021-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214969-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2021-09-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214969-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2021-09-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214969-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-09-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214969-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2021-09-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214969-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2021-09-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214969-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2021-09-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214969-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-09-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214969-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2021-09-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214969-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2021-09-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214969-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2021-09-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214969-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-09-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214969-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2021-09-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214969-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2021-09-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214969-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2021-09-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214969-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-09-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214969-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2021-09-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214969-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2021-09-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214969-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2021-09-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214969-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-09-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214969-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2021-09-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214969-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2021-09-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214969-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2021-09-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214969-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2021-09-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214969-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2021-09-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214969-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2021-09-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214969-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2021-09-02 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 140 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 11 of 13 · 245 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Atorvastatin Calcium ATORVASTATIN CALCIUM Laurus Labs Limited 9f8ca507-b784-4d18-8d3e-d7d68072c416 2024-04-22 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Lipitor ATORVASTATIN CALCIUM Viatris Specialty LLC a60cc18b-0631-4cf0-b021-9f52224ece65 2024-04-15 Warnings, Adverse reactions Name fallback generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM A-S Medication Solutions 1cc2dd41-a465-45b6-a80a-67c41af29cf8 2024-04-10 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM A-S Medication Solutions 2ad89657-cc95-44a0-af6a-ee756526aa10 2024-04-10 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM A-S Medication Solutions 103cc381-3266-409d-bdc2-1de620bae355 2024-04-10 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM A-S Medication Solutions e52b4b11-9618-4787-ae67-44e4a3166dfb 2024-04-10 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM A-S Medication Solutions 0ec97c59-9d17-45f8-93f9-2c1f0361cb75 2024-04-10 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM A-S Medication Solutions e6d068ed-f9d2-4fd1-9755-b76bea89725e 2024-04-10 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Bryant Ranch Prepack 5868d3c2-ae17-4a7e-9580-7c3cf9bf009e 2024-04-05 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM NuCare Pharmaceuticals,Inc. 12751ca4-cde3-92dd-e063-6294a90a4e9d 2024-02-28 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM NuCare Pharmaceuticals,Inc. f7e8c8d2-b74e-6afd-e053-6394a90af83e 2024-02-05 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM Proficient Rx LP acbbd2c4-60bd-4e01-ad7a-b9b3178569f0 2024-01-01 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM A-S Medication Solutions 498ef8e6-3366-42f4-99fe-b3e1dedae887 2023-12-27 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Lupin Pharmaceuticals, Inc. a5767370-15a2-45e5-b980-7af9523aea7b 2023-12-15 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Proficient Rx LP f3af6315-08b5-4ff9-80ae-2984f0598611 2023-12-01 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM A-S Medication Solutions 7afe2137-b8b6-4506-818a-e5fadb2aee51 2023-11-26 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM A-S Medication Solutions 4ed5fd35-8212-4eb4-bf44-aeca788e4e4c 2023-11-26 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM A-S Medication Solutions d97df6ad-87ca-46ec-8de7-4a958ab3b463 2023-11-24 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Aphena Pharma Solutions - Tennessee, LLC 3dbeae00-89ab-48a6-9e57-8048facb2294 2023-10-25 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Proficient Rx LP ba7a8604-93bb-4b82-b160-328ed17f89f9 2023-10-01 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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72134-009 Atorvastatin calcium Atorvastatin calcium tablets Agnitio Inc. ANDA Current 72134-010 Atorvastatin calcium Atorvastatin calcium tablets Agnitio Inc. ANDA Current 72134-011 Atorvastatin calcium Atorvastatin calcium tablets Agnitio Inc. ANDA Current 72134-012 Atorvastatin calcium Atorvastatin calcium tablets Agnitio Inc. ANDA Current 82239-001 Atorvastatin calcium Atorvastatin calcium tablets August Pharmaceutical, LLC ANDA Current 82239-002 Atorvastatin calcium Atorvastatin calcium tablets August Pharmaceutical, LLC ANDA Current 82239-003 Atorvastatin calcium Atorvastatin calcium tablets August Pharmaceutical, LLC ANDA Current 82239-004 Atorvastatin calcium Atorvastatin calcium tablets August Pharmaceutical, LLC ANDA Current