Home Applications 202357 Application 202357
Type ANDA
Sponsor DR REDDYS LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202357-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202357-001 AB
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 · 43 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 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202357-001 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-07-17 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 1 · 1 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0615-7772 Atorvastatin Calcium Atorvastatin Calcium NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 55111-124 Atorvastatin Calcium Atorvastatin Calcium Dr. Reddy's Laboratories Limited ANDA Current 55111-124 Atorvastatin Calcium Atorvastatin Calcium Dr. Reddy's Laboratories Limited ANDA Current 55111-124 Atorvastatin Calcium Atorvastatin Calcium Dr. Reddy's Laboratories Limited ANDA Current 55111-124 Atorvastatin Calcium Atorvastatin Calcium Dr. Reddy's Laboratories Limited ANDA Current 55111-124 Atorvastatin Calcium Atorvastatin Calcium Dr. Reddy's Laboratories Limited ANDA Current 55111-124 Atorvastatin Calcium Atorvastatin Calcium Dr. Reddy's Laboratories Limited ANDA Current 55111-124 Atorvastatin Calcium Atorvastatin Calcium Dr. Reddy's Laboratories Limited ANDA Current 63739-037 Atorvastatin Calcium Atorvastatin Calcium Mckesson Corporation DBA SKY Packaginng ANDA Current 63739-037 Atorvastatin Calcium Atorvastatin Calcium Mckesson Corporation DBA SKY Packaginng ANDA Current 63739-037 Atorvastatin Calcium Atorvastatin Calcium McKesson Corporation dba SKY Packaging ANDA Current 68788-9983 Atorvastatin Calcium Atorvastatin Calcium Preferred Pharmaceuticals, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 43399 ORIG 2015-03-09