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 8 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 Coupler LLC 2fffae44-e536-9645-e063-6394a90a7ce5 2025-03-10 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Coupler LLC 2f2152b6-790c-aa4a-e063-6294a90a3b18 2025-02-27 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Biocon Pharma Inc. 5b839619-1805-c227-91bf-182f5b966ba4 2025-02-26 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Coupler LLC 2de6b9b3-8f3c-599e-e063-6394a90aee60 2025-02-11 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Coupler LLC 2d916667-7b3e-ea20-e063-6294a90a52da 2025-02-07 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Coupler LLC 2d93e3c4-59cc-cff4-e063-6394a90a8f7f 2025-02-07 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM atorvastatin calcium ATORVASTATIN CALCIUM, FILM COATED NuCare Pharmaceuticals,Inc. faba7fc1-2e08-74ef-e053-6394a90afd04 2025-02-04 Warnings, Adverse reactions Name fallback brand name: atorvastatin calcium ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM NuCare Pharmaceuticals, Inc. 51f23212-a10d-4cfa-e054-00144ff88e88 2025-02-04 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM atorvastatin calcium ATORVASTATIN CALCIUM, FILM COATED NuCare Pharmaceuticals,Inc. 0a9d4e36-305a-2120-e063-6294a90a01bd 2025-02-03 Warnings, Adverse reactions Name fallback brand name: atorvastatin calcium Atorvastatin calcium ATORVASTATIN CALCIUM Bryant Ranch Prepack 71cd9b85-4914-4b0b-97db-7aaf25983211 2025-01-31 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Bryant Ranch Prepack 2035c49b-f319-4dce-bf1c-c2f64e786fb7 2025-01-31 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM Coupler LLC 2cd9999b-e18f-09de-e063-6294a90a108b 2025-01-29 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM Coupler LLC 2c67a15c-53b7-f431-e063-6394a90acc50 2025-01-25 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Coupler LLC 2c658654-87ee-b52a-e063-6294a90a11d6 2025-01-23 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Bryant Ranch Prepack 49e0e9e7-447d-4d9d-847e-46d68a77db2d 2025-01-21 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM DIRECT RX c3b70f79-45a3-0869-e053-2a95a90a3cdb 2025-01-20 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM DirectRX d076309f-313a-1c71-e053-2995a90a7bb7 2025-01-20 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM 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
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