Home Applications 079169 Application 079169
Type ANDA
Sponsor SUN PHARM 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 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 A079169-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 A079169-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 A079169-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 A079169-004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19
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 A079169-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079169-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079169-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079169-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079169-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079169-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079169-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079169-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079169-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079169-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079169-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079169-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079169-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079169-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079169-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079169-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079169-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079169-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079169-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079169-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079169-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079169-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079169-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079169-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079169-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079169-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079169-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079169-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079169-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079169-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079169-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079169-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079169-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079169-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079169-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079169-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079169-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079169-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079169-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079169-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-07-19 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 130 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 7 of 7 · 130 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Rosuvastatin Calcium ROSUVASTATIN CALCIUM Proficient Rx LP a9478b12-89d2-42a4-a310-707a87ef43d7 2022-08-01 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM Proficient Rx LP 3066f572-e3db-4bf8-b9ee-bd32d9ed8c13 2022-06-01 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM Proficient Rx LP dcc22d05-cff6-42f9-b9fa-930f2084753f 2022-05-01 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM Proficient Rx LP c40d5c38-3585-47ed-ad81-6ad2da91c9c8 2022-04-01 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin calcium ROSUVASTATIN CALCIUM Aphena Pharma Solutions - Tennessee, LLC a5ee9510-e691-49ec-a5cd-49e70371ee4d 2019-01-09 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin calcium ROSUVASTATIN CALCIUM Aphena Pharma Solutions - Tennessee, LLC 410a0a03-6751-4c3d-82bf-c7c6a4081fdd 2018-11-13 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin calcium ROSUVASTATIN CALCIUM Aphena Pharma Solutions - Tennessee, LLC cbef0681-705c-48fd-add9-1042658ef85d 2018-09-12 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin calcium ROSUVASTATIN CALCIUM Aphena Pharma Solutions - Tennessee, LLC 69dfa637-2a81-4c7e-8fef-d4b4ab4c3f25 2018-06-30 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 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 47335-582 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-582 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-582 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-582 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-582 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-583 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-583 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-583 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-583 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-583 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-584 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-584 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-584 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-584 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-584 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-585 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-585 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-585 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-585 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current 47335-585 Rosuvastatin Calcium Rosuvastatin Calcium Sun Pharmaceutical Industries, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9231 ORIG 2016-07-20