Home Applications 211886 Application 211886
Type ANDA
Sponsor SHANDONG XINHUA 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 A211886-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-25 A211886-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-25 A211886-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-25 A211886-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-25
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 2 · 76 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 A211886-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211886-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211886-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211886-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211886-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211886-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211886-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211886-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211886-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211886-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211886-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211886-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211886-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211886-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211886-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211886-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211886-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211886-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211886-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211886-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211886-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211886-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211886-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211886-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211886-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211886-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211886-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211886-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211886-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211886-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211886-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211886-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211886-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211886-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211886-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211886-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211886-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211886-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211886-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211886-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-25 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 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 12 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 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 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM A-S Medication Solutions 1b8c55ef-160d-42df-95d1-c008f1182e3e 2023-09-14 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM A-S Medication Solutions 107d7aed-582d-4296-99e9-ec63c41a594c 2023-08-24 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM A-S Medication Solutions 77675dc3-868d-42a3-a179-80372a23e0c8 2023-07-21 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM A-S Medication Solutions 0ab0bcac-10a3-4178-9674-3730683a4183 2023-07-21 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM A-S Medication Solutions cbbdd932-a43b-4e88-af6d-cfe994c941b3 2023-05-19 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM A-S Medication Solutions 01eadde8-37f3-4474-995f-22c1a65adf12 2023-04-07 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM A-S Medication Solutions 85c38e0b-3d0b-4b04-990a-ed077a4c43e4 2023-02-06 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM A-S Medication Solutions d3f27113-785c-419e-955a-d6782fade438 2023-02-06 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM A-S Medication Solutions f4154300-65d4-4e31-97ad-b8d086c676e2 2023-02-06 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM Proficient Rx LP 514fcba1-713c-4aeb-be8c-369fcf9b4ffe 2023-02-01 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Proficient Rx LP a1b22973-cb9a-473e-a240-112b3e84e97c 2022-12-01 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Proficient Rx LP 44f0df8b-6069-4941-87e9-2c57c8dfddfa 2022-11-28 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Proficient Rx LP 957feff4-5005-4eea-bbe2-7232be65b0eb 2022-10-01 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Proficient Rx LP a34d3c72-ce91-47c7-86a1-f32caaed2c47 2022-10-01 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Proficient Rx LP e931003a-3a8d-48b9-b13f-e620017303f6 2022-05-01 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Proficient Rx LP 1923c91e-c6dd-4446-aabd-70a0c6aa1a82 2022-04-01 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Aphena Pharma Solutions - Tennessee, LLC 2b7fbe2a-1f7a-4944-b589-87ca05af7481 2022-03-02 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.