Home Applications 213072 Application 213072
Type NDA
Sponsor ALTHERA LIFE SCIENCES, LLC. Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ROSZET ROSUVASTATIN CALCIUM; EZETIMIBE TABLET; ORAL 5MG/10MG Yes No 002 ROSZET ROSUVASTATIN CALCIUM; EZETIMIBE TABLET; ORAL 10MG/10MG Yes No 003 ROSZET ROSUVASTATIN CALCIUM; EZETIMIBE TABLET;ORAL 20MG/10MG Yes No 004 ROSZET ROSUVASTATIN CALCIUM; EZETIMIBE TABLET; ORAL 40MG/10MG Yes 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 N213072-001 ROSZET EZETIMIBE; ROSUVASTATIN CALCIUM 10MG;EQ 5MG BASE TABLET / ORAL RLD 2021-03-23 N213072-002 ROSZET EZETIMIBE; ROSUVASTATIN CALCIUM 10MG;EQ 10MG BASE TABLET / ORAL RLD 2021-03-23 N213072-003 ROSZET EZETIMIBE; ROSUVASTATIN CALCIUM 10MG;EQ 20MG BASE TABLET / ORAL RLD 2021-03-23 N213072-004 ROSZET EZETIMIBE; ROSUVASTATIN CALCIUM 10MG;EQ 40MG BASE TABLET / ORAL RLD 2021-03-23
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213072-001 10376470 2033-05-01 U-3095 Drug product 2021-03-29 N213072-001 9763885 2033-05-01 U-3095 Drug product 2021-03-29 N213072-002 10376470 2033-05-01 U-3095 Drug product 2021-03-29 N213072-002 9763885 2033-05-01 U-3095 Drug product 2021-03-29 N213072-003 10376470 2033-05-01 U-3095 Drug product 2021-03-29 N213072-003 9763885 2033-05-01 U-3095 Drug product 2021-03-29 N213072-004 10376470 2033-05-01 U-3095 Drug product 2021-03-29 N213072-004 9763885 2033-05-01 U-3095 Drug product 2021-03-29
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 4 of 4 · 148 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 2023-05-13 08:27 UTC 2023-05 N213072-001 ROSZET 10MG;EQ 5MG BASE TABLET / ORAL RLD 2021-03-23 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N213072-002 ROSZET 10MG;EQ 10MG BASE TABLET / ORAL RLD 2021-03-23 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N213072-003 ROSZET 10MG;EQ 20MG BASE TABLET / ORAL RLD 2021-03-23 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N213072-004 ROSZET 10MG;EQ 40MG BASE TABLET / ORAL RLD 2021-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213072-001 ROSZET 10MG;EQ 5MG BASE TABLET / ORAL RLD 2021-03-23 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N213072-002 ROSZET 10MG;EQ 10MG BASE TABLET / ORAL RLD 2021-03-23 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N213072-003 ROSZET 10MG;EQ 20MG BASE TABLET / ORAL RLD 2021-03-23 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N213072-004 ROSZET 10MG;EQ 40MG BASE TABLET / ORAL RLD 2021-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213072-001 ROSZET 10MG;EQ 5MG BASE TABLET / ORAL RLD 2021-03-23 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213072-002 ROSZET 10MG;EQ 10MG BASE TABLET / ORAL RLD 2021-03-23 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213072-003 ROSZET 10MG;EQ 20MG BASE TABLET / ORAL RLD 2021-03-23 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213072-004 ROSZET 10MG;EQ 40MG BASE TABLET / ORAL RLD 2021-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213072-001 ROSZET 10MG;EQ 5MG BASE TABLET / ORAL RLD 2021-03-23 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N213072-002 ROSZET 10MG;EQ 10MG BASE TABLET / ORAL RLD 2021-03-23 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N213072-003 ROSZET 10MG;EQ 20MG BASE TABLET / ORAL RLD 2021-03-23 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N213072-004 ROSZET 10MG;EQ 40MG BASE TABLET / ORAL RLD 2021-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213072-001 ROSZET 10MG;EQ 5MG BASE TABLET / ORAL RLD 2021-03-23 e64feba35796…2022-09-29 23:25 UTC 2022-09 N213072-002 ROSZET 10MG;EQ 10MG BASE TABLET / ORAL RLD 2021-03-23 e64feba35796…2022-09-29 23:25 UTC 2022-09 N213072-003 ROSZET 10MG;EQ 20MG BASE TABLET / ORAL RLD 2021-03-23 e64feba35796…2022-09-29 23:25 UTC 2022-09 N213072-004 ROSZET 10MG;EQ 40MG BASE TABLET / ORAL RLD, RS 2021-03-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213072-001 ROSZET 10MG;EQ 5MG BASE TABLET / ORAL RLD 2021-03-23 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213072-002 ROSZET 10MG;EQ 10MG BASE TABLET / ORAL RLD 2021-03-23 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213072-003 ROSZET 10MG;EQ 20MG BASE TABLET / ORAL RLD 2021-03-23 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213072-004 ROSZET 10MG;EQ 40MG BASE TABLET / ORAL RLD, RS 2021-03-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213072-001 ROSZET 10MG;EQ 5MG BASE TABLET / ORAL RLD 2021-03-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213072-002 ROSZET 10MG;EQ 10MG BASE TABLET / ORAL RLD 2021-03-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213072-003 ROSZET 10MG;EQ 20MG BASE TABLET / ORAL RLD 2021-03-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213072-004 ROSZET 10MG;EQ 40MG BASE TABLET / ORAL RLD 2021-03-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 296 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N213072-001 10376470 2033-05-01 U-3095 Drug product 2021-03-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213072-001 9763885 2033-05-01 U-3095 Drug product 2021-03-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213072-002 10376470 2033-05-01 U-3095 Drug product 2021-03-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213072-002 9763885 2033-05-01 U-3095 Drug product 2021-03-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213072-003 10376470 2033-05-01 U-3095 Drug product 2021-03-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213072-003 9763885 2033-05-01 U-3095 Drug product 2021-03-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213072-004 10376470 2033-05-01 U-3095 Drug product 2021-03-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213072-004 9763885 2033-05-01 U-3095 Drug product 2021-03-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 N213072-001 10376470 2033-05-01 U-3095 Drug product 2021-03-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213072-001 9763885 2033-05-01 U-3095 Drug product 2021-03-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213072-002 10376470 2033-05-01 U-3095 Drug product 2021-03-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213072-002 9763885 2033-05-01 U-3095 Drug product 2021-03-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213072-003 10376470 2033-05-01 U-3095 Drug product 2021-03-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213072-003 9763885 2033-05-01 U-3095 Drug product 2021-03-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213072-004 10376470 2033-05-01 U-3095 Drug product 2021-03-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213072-004 9763885 2033-05-01 U-3095 Drug product 2021-03-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213072-001 10376470 2033-05-01 U-3095 Drug product 2021-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213072-001 9763885 2033-05-01 U-3095 Drug product 2021-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213072-002 10376470 2033-05-01 U-3095 Drug product 2021-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213072-002 9763885 2033-05-01 U-3095 Drug product 2021-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213072-003 10376470 2033-05-01 U-3095 Drug product 2021-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213072-003 9763885 2033-05-01 U-3095 Drug product 2021-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213072-004 10376470 2033-05-01 U-3095 Drug product 2021-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213072-004 9763885 2033-05-01 U-3095 Drug product 2021-03-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213072-001 10376470 2033-05-01 U-3095 Drug product 2021-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213072-001 9763885 2033-05-01 U-3095 Drug product 2021-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213072-002 10376470 2033-05-01 U-3095 Drug product 2021-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213072-002 9763885 2033-05-01 U-3095 Drug product 2021-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213072-003 10376470 2033-05-01 U-3095 Drug product 2021-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213072-003 9763885 2033-05-01 U-3095 Drug product 2021-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213072-004 10376470 2033-05-01 U-3095 Drug product 2021-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213072-004 9763885 2033-05-01 U-3095 Drug product 2021-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213072-001 10376470 2033-05-01 U-3095 Drug product 2021-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213072-001 9763885 2033-05-01 U-3095 Drug product 2021-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213072-002 10376470 2033-05-01 U-3095 Drug product 2021-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213072-002 9763885 2033-05-01 U-3095 Drug product 2021-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213072-003 10376470 2033-05-01 U-3095 Drug product 2021-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213072-003 9763885 2033-05-01 U-3095 Drug product 2021-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213072-004 10376470 2033-05-01 U-3095 Drug product 2021-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213072-004 9763885 2033-05-01 U-3095 Drug product 2021-03-29 31067a03dcf5…
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 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70661-001 ROSZET (rosuvastatin and ezetimibe) Althera Pharmaceuticals LLC NDA Current 70661-001 ROSZET rosuvastatin and ezetimibe Althera Pharmaceuticals LLC NDA Current 70661-001 ROSZET rosuvastatin and ezetimibe Althera Pharmaceuticals LLC NDA Current 70661-002 ROSZET (rosuvastatin and ezetimibe) Althera Pharmaceuticals LLC NDA Current 70661-002 ROSZET (rosuvastatin and ezetimibe) Althera Pharmaceuticals LLC NDA Current 70661-002 ROSZET (rosuvastatin and ezetimibe) Althera Pharmaceuticals LLC NDA Current 70661-003 ROSZET (rosuvastatin and ezetimibe) Althera Pharmaceuticals LLC NDA Current 70661-003 ROSZET (rosuvastatin and ezetimibe) Althera Pharmaceuticals LLC NDA Current 70661-003 ROSZET (rosuvastatin and ezetimibe) Althera Pharmaceuticals LLC NDA Current 70661-004 ROSZET (rosuvastatin and ezetimibe) Althera Pharmaceuticals LLC NDA Current 70661-004 ROSZET (rosuvastatin and ezetimibe) Althera Pharmaceuticals LLC NDA Current 70661-004 ROSZET (rosuvastatin and ezetimibe) Althera Pharmaceuticals LLC NDA Current 82120-125 ROSUVASTATIN AND EZETIMIBE rosuvastatin and ezetimibe SCOV3 LLC NDA AUTHORIZED GENERIC Current 82120-126 ROSUVASTATIN AND EZETIMIBE rosuvastatin and ezetimibe SCOV3 LLC NDA AUTHORIZED GENERIC Current 82120-127 ROSUVASTATIN AND EZETIMIBE rosuvastatin and ezetimibe SCOV3 LLC NDA AUTHORIZED GENERIC Current 82120-128 ROSUVASTATIN AND EZETIMIBE rosuvastatin and ezetimibe SCOV3 LLC NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 79497 SUPPL 2024-08-29 79488 SUPPL 2024-08-27 69080 ORIG 2021-10-25 66877 ORIG 2021-03-25 66861 ORIG 2021-03-24