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 5 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 QPharma, Inc. f7cc5704-2131-4bcb-9ff0-33a79a8167bd 2025-12-05 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM A-S Medication Solutions 06abf2dc-5ebd-4d42-b43c-7deeb93925dd 2025-12-04 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM A-S Medication Solutions 811e6733-fa82-4b41-b426-fe24aa70e601 2025-12-04 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM QPharma, Inc. d8a72abf-1d43-47e1-88e8-c3c5cc4ba163 2025-12-03 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM QPharma, Inc. bd216f5d-f319-7d8d-e053-2a95a90aa9ce 2025-12-01 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM QPharma, Inc. c0e2a5d0-1aa3-e131-e053-2a95a90a9870 2025-12-01 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Bryant Ranch Prepack 44a39b5a-77b6-42e8-9319-df21d3678e02 2025-11-12 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Bryant Ranch Prepack 635addf1-2024-4675-8d3c-380dc4548fbd 2025-11-11 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 7353f9ef-6f79-4522-886a-7a8ae4eb867e 2025-11-11 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Bryant Ranch Prepack 66df5c0b-be89-4fc7-8f8d-c7689952c662 2025-11-11 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Bryant Ranch Prepack 271409d0-5500-4ed0-8730-5a93226a2191 2025-11-11 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM, FILM COATED NuCare Pharmaceuticals, Inc. 4344f574-9b86-7ae5-e063-6294a90a79e8 2025-11-10 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium Atorvastatin calcium ATORVASTATIN CALCIUM Bryant Ranch Prepack ec1d1722-d035-4a8b-b3ab-d2d93f2fd4bb 2025-11-06 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM atorvastatin calcium ATORVASTATIN CALCIUM Lepu Pharmaceutical Technology Co., Ltd. 173474b6-26b4-46f2-a12a-64753ae5e905 2025-10-29 Warnings, Adverse reactions Name fallback brand name: atorvastatin calcium generic name: ATORVASTATIN CALCIUM atorvastatin calcium ATORVASTATIN CALCIUM A-S Medication Solutions 993c39c2-afe6-4b92-9251-5695f4524a70 2025-10-21 Warnings, Adverse reactions Name fallback brand name: atorvastatin calcium generic name: ATORVASTATIN CALCIUM atorvastatin calcium ATORVASTATIN CALCIUM A-S Medication Solutions f6bc1ac6-c96c-4ecf-9935-733587ad6107 2025-10-21 Warnings, Adverse reactions Name fallback brand name: atorvastatin calcium generic name: ATORVASTATIN CALCIUM atorvastatin calcium ATORVASTATIN CALCIUM A-S Medication Solutions a102dd8f-25c8-48fa-8244-2d1675f1e1b3 2025-10-21 Warnings, Adverse reactions Name fallback brand name: atorvastatin calcium generic name: ATORVASTATIN CALCIUM atorvastatin calcium ATORVASTATIN CALCIUM A-S Medication Solutions af38f580-ce13-436a-a7e3-853c5ac8e540 2025-10-21 Warnings, Adverse reactions Name fallback brand name: atorvastatin calcium generic name: ATORVASTATIN CALCIUM atorvastatin calcium ATORVASTATIN CALCIUM A-S Medication Solutions befeea30-acf5-425d-bdea-5c79a9ebfad8 2025-10-21 Warnings, Adverse reactions Name fallback brand name: atorvastatin calcium generic name: ATORVASTATIN CALCIUM atorvastatin calcium ATORVASTATIN CALCIUM A-S Medication Solutions 54f93ed0-64ef-46bb-aab6-a8dd5dc4c035 2025-10-21 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