Home Applications 209288 Application 209288
Type ANDA
Sponsor THEPHARMANETWORK LLC 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 A209288-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 A209288-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 A209288-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 A209288-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21
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 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 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 2 of 2 · 21 matching rows.
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 · 68 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42708-141 Atorvastatin Calcium Atorvastatin Calcium QPharma Inc ANDA Current 42708-141 Atorvastatin Calcium Atorvastatin Calcium QPharma Inc ANDA Current 42708-144 Atorvastatin Calcium Atorvastatin Calcium QPharma Inc ANDA Current 42708-144 Atorvastatin Calcium Atorvastatin Calcium QPharma, Inc. ANDA Current 50090-5181 Atorvastatin Calcium Atorvastatin Calcium A-S Medication Solutions ANDA Current 50090-5182 Atorvastatin Calcium Atorvastatin Calcium A-S Medication Solutions ANDA Current 50090-5182 Atorvastatin Calcium Atorvastatin Calcium A-S Medication Solutions ANDA Current 50090-5184 Atorvastatin Calcium Atorvastatin Calcium A-S Medication Solutions ANDA Current 50090-5185 Atorvastatin Calcium Atorvastatin Calcium A-S Medication Solutions ANDA Current 50090-5207 Atorvastatin Calcium Atorvastatin Calcium A-S Medication Solutions ANDA Current 50090-5207 Atorvastatin Calcium Atorvastatin Calcium A-S Medication Solutions ANDA Current 50090-5208 Atorvastatin Calcium Atorvastatin Calcium A-S Medication Solutions ANDA Current 50090-5208 Atorvastatin Calcium Atorvastatin Calcium A-S Medication Solutions ANDA Current 50090-6061 Atorvastatin Calcium Atorvastatin Calcium A-S Medication Solutions ANDA Current 51655-464 Atorvastatin Calcium Atorvastatin Calcium Northwind Pharmaceuticals, LLC ANDA Current 60760-709 Atorvastatin Calcium Atorvastatin Calcium St. Mary's Medical Park Pharmacy ANDA Current 67877-511 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-511 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-511 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-511 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-511 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-512 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-512 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-512 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-512 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-512 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-513 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-513 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-513 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-513 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-513 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-514 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-514 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-514 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-514 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 67877-514 Atorvastatin Calcium Atorvastatin Calcium Ascend Laboratories, LLC ANDA Current 68071-4806 Atorvastatin Calcium Atorvastatin Calcium NuCare Pharmaceuticals,Inc. ANDA Current 68071-4806 Atorvastatin Calcium Atorvastatin Calcium NuCare Pharmaceuticals,Inc. ANDA Current 68071-4835 Atorvastatin Calcium Atorvastatin Calcium NuCare Pharmaceuticals,Inc. ANDA Current 68071-4835 Atorvastatin Calcium Atorvastatin Calcium NuCare Pharmaceuticals,Inc. ANDA Current 68071-4837 Atorvastatin Calcium Atorvastatin Calcium NuCare Pharmaceuticals,Inc. ANDA Current 68071-4837 Atorvastatin Calcium Atorvastatin Calcium NuCare Pharmaceuticals,Inc. ANDA Current 68071-4840 Atorvastatin Calcium Atorvastatin Calcium NuCare Pharmaceuticals,Inc. ANDA Current 68071-4840 Atorvastatin Calcium Atorvastatin Calcium NuCare Pharmaceuticals,Inc. ANDA Current 68071-5008 Atorvastatin Calcium Atorvastatin Calcium NuCare Pharmaceuticals,Inc. ANDA Current 68071-5008 Atorvastatin Calcium Atorvastatin Calcium NuCare Pharmaceuticals,Inc. ANDA Current 68071-5091 Atorvastatin Calcium Atorvastatin Calcium NuCare Pharmaceuticals,Inc. ANDA Current 68071-5091 Atorvastatin Calcium Atorvastatin Calcium NuCare Pharmaceuticals,Inc. ANDA Current 68788-7525 Atorvastatin Calcium Atorvastatin Calcium Preferred Pharmaceuticals Inc. ANDA Current 68788-7525 Atorvastatin Calcium Atorvastatin Calcium Preferred Pharmaceuticals Inc. ANDA Current 68788-7525 Atorvastatin Calcium Atorvastatin Calcium Preferred Pharmaceuticals Inc. ANDA Current 68788-7900 Atorvastatin Calcium Atorvastatin Calcium Preferred Pharmaceuticals Inc. ANDA Current 68788-7900 Atorvastatin Calcium Atorvastatin Calcium Preferred Pharmaceuticals Inc. ANDA Current 68788-7986 Atorvastatin Calcium Atorvastatin Calcium Preferred Pharmaceuticals Inc. ANDA Current 68788-7986 Atorvastatin Calcium Atorvastatin Calcium Preferred Pharmaceuticals Inc. ANDA Current 68788-7986 Atorvastatin Calcium Atorvastatin Calcium Preferred Pharmaceuticals Inc. ANDA Current 70518-3037 Atorvastatin Calcium Atorvastatin Calcium REMEDYREPACK INC. ANDA Current 70518-3037 Atorvastatin Calcium Atorvastatin Calcium REMEDYREPACK INC. ANDA Current 70934-482 Atorvastatin Calcium Atorvastatin Calcium Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-614 Atorvastatin Calcium Atorvastatin Calcium Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 70934-614 Atorvastatin Calcium Atorvastatin Calcium Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 70934-615 Atorvastatin Calcium Atorvastatin Calcium Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 70934-841 Atorvastatin Calcium Atorvastatin Calcium Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-841 Atorvastatin Calcium Atorvastatin Calcium Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 70934-841 Atorvastatin Calcium Atorvastatin Calcium Denton Pharma, Inc. DBA Northwind Pharmaceuticals ANDA Current 71335-1247 Atorvastatin Calcium Atorvastatin Calcium Bryant Ranch Prepack ANDA Current 71335-1247 Atorvastatin Calcium Atorvastatin Calcium Bryant Ranch Prepack ANDA Current 71335-1247 Atorvastatin Calcium Atorvastatin Calcium Bryant Ranch Prepack ANDA Current