Home Applications 079167 Application 079167
Type ANDA
Sponsor WATSON LABS INC 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 A079167-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-04-29 A079167-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-04-29 A079167-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-04-29 A079167-004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-04-29
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 A079167-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079167-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079167-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079167-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079167-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079167-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079167-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079167-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079167-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079167-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079167-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079167-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079167-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079167-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079167-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079167-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079167-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079167-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079167-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079167-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079167-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079167-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079167-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079167-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079167-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079167-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079167-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079167-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079167-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079167-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079167-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079167-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079167-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-04-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079167-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-04-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079167-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-04-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079167-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079167-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-04-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079167-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-04-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079167-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-04-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079167-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-04-29 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 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 · 133 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 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 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
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0904-6602 Rosuvastatin Calcium Rosuvastatin calcium Major Pharmaceuticals ANDA Current 0904-6603 Rosuvastatin Calcium Rosuvastatin calcium Major Pharmaceuticals ANDA Current 0904-6604 Rosuvastatin Calcium Rosuvastatin calcium Major Pharmaceuticals ANDA Current 0904-6605 Rosuvastatin Calcium Rosuvastatin calcium Major Pharmaceuticals ANDA Current 50090-2805 Rosuvastatin Calcium Rosuvastatin calcium A-S Medication Solutions ANDA Current 70518-0167 Rosuvastatin Calcium Rosuvastatin calcium REMEDYREPACK INC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 39567 ORIG 2016-05-03 31419 ORIG 2016-05-03