Home Applications 206513 Application 206513
Type ANDA
Sponsor ZYDUS PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 5MG No No 002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 10MG No No 003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 20MG No No 004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL 40MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A206513-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-03-01 A206513-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-03-01 A206513-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-03-01 A206513-004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-03-01
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 · 168 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 2026-08-18 06:07:40 2026-07 A206513-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206513-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206513-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-03-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206513-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-03-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206513-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206513-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206513-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-03-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206513-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206513-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206513-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206513-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-03-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206513-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206513-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206513-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206513-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-03-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206513-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206513-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2019-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206513-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2019-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206513-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2019-03-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206513-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2019-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206513-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2019-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206513-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2019-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206513-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2019-03-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206513-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2019-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206513-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2019-03-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206513-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2019-03-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206513-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2019-03-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206513-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2019-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206513-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2019-03-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206513-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2019-03-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206513-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2019-03-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206513-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2019-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206513-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2019-03-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206513-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2019-03-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206513-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2019-03-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206513-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2019-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206513-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2019-03-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206513-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2019-03-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206513-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2019-03-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206513-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2019-03-01 d8e5a09893c0…
Observed Orange Book normalized TE history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 17 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68382-627 Rosuvastatin Rosuvastatin Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-627 Rosuvastatin Rosuvastatin Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-628 Rosuvastatin Rosuvastatin Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-628 Rosuvastatin Rosuvastatin Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-629 Rosuvastatin Rosuvastatin Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-629 Rosuvastatin Rosuvastatin Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-630 Rosuvastatin Rosuvastatin Zydus Pharmaceuticals (USA) Inc. ANDA Current 68382-630 Rosuvastatin Rosuvastatin Zydus Pharmaceuticals (USA) Inc. ANDA Current 70771-1481 Rosuvastatin Rosuvastatin Cadila Healthcare Limited ANDA Current 70771-1481 Rosuvastatin Rosuvastatin Cadila Healthcare Limited ANDA Current 70771-1482 Rosuvastatin Rosuvastatin Cadila Healthcare Limited ANDA Current 70771-1482 Rosuvastatin Rosuvastatin Cadila Healthcare Limited ANDA Current 70771-1483 Rosuvastatin Rosuvastatin Cadila Healthcare Limited ANDA Current 70771-1483 Rosuvastatin Rosuvastatin Cadila Healthcare Limited ANDA Current 70771-1483 Rosuvastatin Rosuvastatin Zydus Lifesciences Limited ANDA Current 70771-1484 Rosuvastatin Rosuvastatin Cadila Healthcare Limited ANDA Current 70771-1484 Rosuvastatin Rosuvastatin Cadila Healthcare Limited ANDA Current