Home Applications 207296 Application 207296
Type ANDA
Sponsor MACLEODS PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 5MG BASE No No 002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 10MG BASE No No 003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 20MG BASE No No 004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM TABLET;ORAL EQ 40MG BASE 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 A207296-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2024-11-06 A207296-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2024-11-06 A207296-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2024-11-06 A207296-004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2024-11-06
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.
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 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2024-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2024-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2024-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2024-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2024-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2024-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2024-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2024-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2024-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2024-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2024-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2024-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2024-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2024-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-11-06 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2024-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-11-06 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2024-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2024-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2024-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2024-11-06 a50c72e98297…
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.