Home Applications 079161 Application 079161
Type ANDA
Sponsor MYLAN 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 A079161-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 A079161-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 A079161-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 A079161-004 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 A079161-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079161-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079161-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079161-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079161-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079161-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079161-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079161-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079161-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079161-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079161-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079161-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079161-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079161-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079161-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079161-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079161-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079161-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079161-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079161-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079161-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079161-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079161-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079161-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079161-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079161-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079161-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079161-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079161-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079161-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079161-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079161-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079161-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079161-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079161-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079161-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079161-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079161-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079161-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079161-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 5bbf6a4d5a75…
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 4 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 Bryant Ranch Prepack 3dd06868-6b71-4ddd-bc9c-57e1cf6656a5 2025-01-24 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 9ac62b17-38d3-4299-b36a-55db1dd9a8ec 2025-01-14 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions de59ab29-4266-4d8d-934c-8d6cf502a8a3 2025-01-14 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS 9333c674-5714-41ed-8a16-dc7c3e50b9a4 2025-01-08 Warnings, Adverse reactions Name fallback brand name: ROSUVASTATIN CALCIUM generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 3debe076-4af2-456f-9c27-8ff81d6aec1b 2025-01-08 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions dc412660-67d4-4371-a6f0-bdd1b5f28bbd 2025-01-08 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions a1021325-c108-41b9-91dc-f1202730bfd1 2025-01-08 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 98bf4f79-2d42-4b69-966b-2275189a4d4d 2024-12-31 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 216d8a80-9bc6-493a-90d3-a00926b49572 2024-12-31 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 7a969720-7994-43a1-97c0-5e7842ae2be4 2024-12-30 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM Proficient Rx LP dc7bfc79-9ee3-46e7-b55d-aba88648ad3b 2024-12-01 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM Novadoz Pharmaceuticals LLC d58f1f63-4bb6-413c-9730-ded3e8078618 2024-11-28 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 0ec87d67-4fe0-4f5a-aa6b-114042ebc249 2024-10-28 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions d147d4b2-5c2a-44d2-abb6-e77715f2b0f5 2024-10-28 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM A-S Medication Solutions 8030f0bc-fb11-4c85-8058-ed6482689d1a 2024-10-28 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM Bryant Ranch Prepack 1c97c9da-687b-47c1-9b9e-61f9a37bb9c4 2024-10-08 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM NCS HealthCare of KY, LLC dba Vangard Labs d84f596d-8b99-419c-9a02-4b5e26aeaea8 2024-09-27 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM Bryant Ranch Prepack a9a5641f-9b7d-4a98-8dac-a3c53dde861f 2024-08-29 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM Bryant Ranch Prepack 199df185-dab0-4de1-95f7-a70e57b9c2b1 2024-08-29 Warnings, Adverse reactions Name fallback brand name: Rosuvastatin Calcium generic name: ROSUVASTATIN CALCIUM Rosuvastatin Calcium ROSUVASTATIN CALCIUM Bryant Ranch Prepack c277c6fd-f8dd-41d8-8686-38c25d05d192 2024-08-29 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 · 13 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-2201 Rosuvastatin Calcium rosuvastatin calcium Mylan Pharmaceuticals Inc. ANDA Current 0378-2201 Rosuvastatin Calcium rosuvastatin calcium Mylan Pharmaceuticals Inc ANDA Current 0378-2203 Rosuvastatin Calcium rosuvastatin calcium Mylan Pharmaceuticals Inc. ANDA Current 0378-2203 Rosuvastatin Calcium rosuvastatin calcium Mylan Pharmaceuticals Inc ANDA Current 0378-2204 Rosuvastatin Calcium rosuvastatin calcium Mylan Pharmaceuticals Inc. ANDA Current 0378-2204 Rosuvastatin Calcium rosuvastatin calcium Mylan Pharmaceuticals Inc ANDA Current 0378-2232 Rosuvastatin Calcium rosuvastatin calcium Mylan Pharmaceuticals Inc. ANDA Current 0378-2232 Rosuvastatin Calcium rosuvastatin calcium Mylan Pharmaceuticals Inc ANDA Current 42292-029 Rosuvastatin Calcium rosuvastatin calcium Mylan Institutional Inc. ANDA Current 42292-030 Rosuvastatin Calcium rosuvastatin calcium Mylan Institutional Inc. ANDA Current 42292-031 Rosuvastatin Calcium rosuvastatin calcium Mylan Institutional Inc. ANDA Current 42292-032 Rosuvastatin Calcium rosuvastatin calcium Mylan Institutional Inc. ANDA Current 50090-2458 Rosuvastatin Calcium rosuvastatin calcium A-S Medication Solutions ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 31417 ORIG 2016-07-20 9228 ORIG 2010-05-17