Home Applications 204846 Application 204846
Type ANDA
Sponsor INVAGEN PHARMS 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 A204846-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-01-09 A204846-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-01-09 A204846-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-01-09 A204846-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL 2017-01-09
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 A204846-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204846-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204846-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-01-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204846-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL 2017-01-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204846-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204846-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204846-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-01-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204846-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL 2017-01-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204846-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204846-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204846-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204846-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL 2017-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204846-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204846-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204846-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204846-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL 2017-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204846-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204846-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204846-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204846-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL 2017-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204846-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204846-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204846-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204846-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL 2017-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204846-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204846-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204846-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204846-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL 2017-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204846-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204846-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204846-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204846-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL 2017-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204846-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-01-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204846-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-01-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204846-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-01-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204846-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL 2017-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204846-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-01-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204846-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-01-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204846-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-01-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204846-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL 2017-01-09 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 3 · 104 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 1 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 Quallent f00a83aa-3f1d-566d-b9bb-f396f22a27cb 2026-09-08 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Apotex Corp. d9adb9e4-c495-9530-e5e3-7e3b01d53e4c 2026-09-08 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM REMEDYREPACK INC. 604a011e-6c64-4895-8f6e-d28f119c4c22 2026-09-04 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM REMEDYREPACK INC. 57f9b462-f08e-483c-9b64-b7e4c8d46927 2026-08-27 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM St. Mary's Medical Park Pharmacy 2e20a00c-b373-3a8c-e063-6294a90a637b 2026-08-25 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Major Pharmaceuticals 634ec8e3-6d83-4cb2-90a3-fc9c973b06bf 2026-08-21 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM REMEDYREPACK INC. d57720ab-9f83-4da9-a57f-0d55e00a605c 2026-08-17 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ScieGen Pharmaceuticals, Inc. f2d8b5e9-6ff2-4efa-ab01-e13df29f7371 2026-08-07 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM REMEDYREPACK INC. 5b3c3043-9af6-48eb-8b10-528e58c88e48 2026-08-06 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM REMEDYREPACK INC. 51e24220-3374-4e5e-9a8d-4113002c5bed 2026-08-06 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM REMEDYREPACK INC. b0bbab86-6789-4ffb-8f84-ee91b69fdb34 2026-08-06 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM REMEDYREPACK INC. 9786388d-ac8d-4646-9fe4-b33e8fda86b2 2026-08-05 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM REMEDYREPACK INC. 09cb8375-075c-47e8-a4eb-8ac667ed849e 2026-07-31 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Cardinal Health 107, LLC aee307d6-b3fa-424f-8656-1f30ff413e95 2026-07-30 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM Major Pharmaceuticals e74278b6-31fc-48d4-97b7-ba500e9e15fb 2026-07-27 Warnings, Adverse reactions Name fallback brand name: ATORVASTATIN CALCIUM generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Cardinal Health 107, LLC fbd1c5da-67fb-4412-acb5-4d4c74a43654 2026-07-24 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin calcium ATORVASTATIN CALCIUM Macleods Pharmaceuticals Limited 7bd0f0ec-f7a3-4403-9a1a-11f18213631f 2026-07-15 Warnings, Adverse reactions Name fallback brand name: Atorvastatin calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Direct_Rx 56a9e58f-567e-30cc-e063-6294a90a290f 2026-07-15 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM Atorvastatin Calcium ATORVASTATIN CALCIUM Bryant Ranch Prepack 2e583569-499d-4f20-87ca-84e7d9868d22 2026-07-14 Warnings, Adverse reactions Name fallback brand name: Atorvastatin Calcium generic name: ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM NORTHSTAR RX LLC 52d8508b-aa98-cd89-5991-e2b5f982b6c6 2026-07-08 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.
Documents# Document, Submission type, Date table Document Submission type Date 46855 ORIG 2017-01-17