Home Applications 205587 Application 205587
Type ANDA
Sponsor LUPIN LTD 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 44 .
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 A205587-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2017-07-31 A205587-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-07-31 A205587-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-07-31 A205587-004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-07-31
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 · 176 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 2026-10-15 13:18:30 2026-09 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2017-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-07-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2017-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-07-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2017-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2017-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-07-31 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 156 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 6 of 7 · 128 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rosuvastatin calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 9b8f614f-d49c-464b-b580-5fb9f2c25681 2023-09-14 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 7b2fc012-bf45-4a27-9e48-67926972918d 2023-09-10 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 2e998dc7-e2a5-41e4-8758-aff545bb1f14 2023-09-06 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 3a138e43-f123-47d1-b241-d3bcc7584e51 2023-09-06 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 8046d4fa-bd89-49f7-8204-9eb49b648748 2023-08-31 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 86fde296-d1c5-4fe8-9050-77c074914f63 2023-08-31 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions ee4f7a00-b330-47ed-8440-7317b43753cf 2023-08-31 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM Proficient Rx LP 76bbea68-52d8-4ba9-a772-0ba75a38f2eb 2023-07-01 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions e24da1b9-e51d-489a-85f4-43227c210477 2023-06-15 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 5f392edb-f7fc-40b4-8446-35494e83a69e 2023-06-14 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 0514e340-54a7-470c-8072-c8113fddf2d9 2023-04-19 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM Aphena Pharma Solutions - Tennessee, LLC ab6c1601-5152-443c-98a0-876660d533e8 2023-03-20 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions ac89adcd-3226-4a66-8902-0f0a33be159a 2023-03-15 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 2aa6d21f-426a-42b0-aa96-4cc47f97f7ab 2023-02-06 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 3aa55393-11c9-4c31-8697-ecaad8c78857 2023-02-06 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM Proficient Rx LP eaf91ddd-0d4f-4c77-9dba-a2a3abb86ea4 2022-11-01 Warnings, Adverse reactions Name fallback brand name: ROSUVASTATIN CALCIUM generic name: ROSUVASTATIN CALCIUM Rosuvastatin calcium ROSUVASTATIN CALCIUM Proficient Rx LP d1bd91fd-03fa-4e6c-80c1-ce58b158d8d6 2022-11-01 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin calcium ROSUVASTATIN CALCIUM Proficient Rx LP aa64d28f-0926-4ff2-bb28-578e5ef233eb 2022-11-01 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin calcium ROSUVASTATIN CALCIUM Proficient Rx LP a1b4d50b-eda3-437c-9c80-4d854361ddc2 2022-11-01 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin calcium ROSUVASTATIN CALCIUM Proficient Rx LP 5a874865-3cbe-4589-9787-046feb9a2c46 2022-11-01 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68180-730 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM Lupin Pharmaceuticals, Inc. ANDA Current 68180-731 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM Lupin Pharmaceuticals, Inc. ANDA Current 68180-732 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM Lupin Pharmaceuticals, Inc. ANDA Current 68180-733 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM Lupin Pharmaceuticals, Inc. ANDA Current