Home Applications 206084 Application 206084
Type ANDA
Sponsor SCOV3 Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EZETIMIBE AND ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM; EZETIMIBE TABLET;ORAL EQ 10MG BASE;10MG No No 002 EZETIMIBE AND ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM; EZETIMIBE TABLET;ORAL EQ 20MG BASE;10MG No No 003 EZETIMIBE AND ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM; EZETIMIBE TABLET;ORAL EQ 40MG BASE;10MG No No 004 EZETIMIBE AND ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM; EZETIMIBE TABLET;ORAL EQ 80MG BASE;10MG No Yes
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 A206084-001 LYPQOZET ATORVASTATIN CALCIUM; EZETIMIBE EQ 10MG BASE;10MG TABLET / ORAL 2017-04-26 A206084-002 LYPQOZET ATORVASTATIN CALCIUM; EZETIMIBE EQ 20MG BASE;10MG TABLET / ORAL 2017-04-26 A206084-003 LYPQOZET ATORVASTATIN CALCIUM; EZETIMIBE EQ 40MG BASE;10MG TABLET / ORAL 2017-04-26 A206084-004 LYPQOZET ATORVASTATIN CALCIUM; EZETIMIBE EQ 80MG BASE;10MG TABLET / ORAL 2017-04-26
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 A206084-001 LYPQOZET EQ 10MG BASE;10MG TABLET / ORAL 2017-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206084-002 LYPQOZET EQ 20MG BASE;10MG TABLET / ORAL 2017-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206084-003 LYPQOZET EQ 40MG BASE;10MG TABLET / ORAL 2017-04-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206084-004 LYPQOZET EQ 80MG BASE;10MG TABLET / ORAL 2017-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206084-001 LYPQOZET EQ 10MG BASE;10MG TABLET / ORAL 2017-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206084-002 LYPQOZET EQ 20MG BASE;10MG TABLET / ORAL 2017-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206084-003 LYPQOZET EQ 40MG BASE;10MG TABLET / ORAL 2017-04-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206084-004 LYPQOZET EQ 80MG BASE;10MG TABLET / ORAL RS 2017-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206084-001 LYPQOZET EQ 10MG BASE;10MG TABLET / ORAL 2017-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206084-002 LYPQOZET EQ 20MG BASE;10MG TABLET / ORAL 2017-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206084-003 LYPQOZET EQ 40MG BASE;10MG TABLET / ORAL 2017-04-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206084-004 LYPQOZET EQ 80MG BASE;10MG TABLET / ORAL RS 2017-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206084-001 LYPQOZET EQ 10MG BASE;10MG TABLET / ORAL 2017-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206084-002 LYPQOZET EQ 20MG BASE;10MG TABLET / ORAL 2017-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206084-003 LYPQOZET EQ 40MG BASE;10MG TABLET / ORAL 2017-04-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206084-004 LYPQOZET EQ 80MG BASE;10MG TABLET / ORAL RS 2017-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206084-001 LYPQOZET EQ 10MG BASE;10MG TABLET / ORAL 2017-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206084-002 LYPQOZET EQ 20MG BASE;10MG TABLET / ORAL 2017-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206084-003 LYPQOZET EQ 40MG BASE;10MG TABLET / ORAL 2017-04-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206084-004 LYPQOZET EQ 80MG BASE;10MG TABLET / ORAL RS 2017-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206084-001 LYPQOZET EQ 10MG BASE;10MG TABLET / ORAL 2017-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206084-002 LYPQOZET EQ 20MG BASE;10MG TABLET / ORAL 2017-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206084-003 LYPQOZET EQ 40MG BASE;10MG TABLET / ORAL 2017-04-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206084-004 LYPQOZET EQ 80MG BASE;10MG TABLET / ORAL RS 2017-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206084-001 LYPQOZET EQ 10MG BASE;10MG TABLET / ORAL 2017-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206084-002 LYPQOZET EQ 20MG BASE;10MG TABLET / ORAL 2017-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206084-003 LYPQOZET EQ 40MG BASE;10MG TABLET / ORAL 2017-04-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206084-004 LYPQOZET EQ 80MG BASE;10MG TABLET / ORAL RS 2017-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206084-001 LYPQOZET EQ 10MG BASE;10MG TABLET / ORAL 2017-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206084-002 LYPQOZET EQ 20MG BASE;10MG TABLET / ORAL 2017-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206084-003 LYPQOZET EQ 40MG BASE;10MG TABLET / ORAL 2017-04-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206084-004 LYPQOZET EQ 80MG BASE;10MG TABLET / ORAL RS 2017-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206084-001 LYPQOZET EQ 10MG BASE;10MG TABLET / ORAL 2017-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206084-002 LYPQOZET EQ 20MG BASE;10MG TABLET / ORAL 2017-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206084-003 LYPQOZET EQ 40MG BASE;10MG TABLET / ORAL 2017-04-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206084-004 LYPQOZET EQ 80MG BASE;10MG TABLET / ORAL RS 2017-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206084-001 LYPQOZET EQ 10MG BASE;10MG TABLET / ORAL 2017-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206084-002 LYPQOZET EQ 20MG BASE;10MG TABLET / ORAL 2017-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206084-003 LYPQOZET EQ 40MG BASE;10MG TABLET / ORAL 2017-04-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206084-004 LYPQOZET EQ 80MG BASE;10MG TABLET / ORAL RS 2017-04-26 d8e5a09893c0…
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70661-005 LYPQOZET (ezetimibe and atorvastatin) Althera Pharmaceuticals, LLC ANDA Current 70661-006 LYPQOZET (ezetimibe and atorvastatin) Althera Pharmaceuticals, LLC ANDA Current 70661-007 LYPQOZET (ezetimibe and atorvastatin) Althera Pharmaceuticals, LLC ANDA Current 70661-008 LYPQOZET (ezetimibe and atorvastatin) Althera Pharmaceuticals, LLC ANDA Current 82120-125 ROSUVASTATIN AND EZETIMIBE rosuvastatin and ezetimibe SCOV3 LLC ANDA Current 82120-126 ROSUVASTATIN AND EZETIMIBE rosuvastatin and ezetimibe SCOV3 LLC ANDA Current 82120-127 ROSUVASTATIN AND EZETIMIBE rosuvastatin and ezetimibe SCOV3 LLC ANDA Current 82120-128 ROSUVASTATIN AND EZETIMIBE rosuvastatin and ezetimibe SCOV3 LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 48206 ORIG 2017-05-02