Home Applications 213260 Application 213260
Type NDA
Sponsor CMP DEV LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ATORVALIQ ATORVASTATIN CALCIUM SUSPENSION;ORAL 20MG/5ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213260-001 ATORVALIQ ATORVASTATIN CALCIUM 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213260-001 11369567 2037-06-07 Drug product 2023-02-07 N213260-001 11654106 2037-06-07 U-3612 Drug product 2023-06-01 N213260-001 11654106 2037-06-07 U-3613 Drug product 2023-06-01 N213260-001 11925704 2037-06-07 U-3853 Drug product 2024-03-25 N213260-001 12168069 2037-06-07 Drug product 2024-12-19 N213260-001 12370136 2037-06-07 Drug product 2025-07-30 N213260-001 12599553 2037-06-07 Drug product 2026-05-06
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.
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 2026-02-19 14:30 UTC 2026-02 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213260-001 ATORVALIQ 20MG/5ML SUSPENSION / ORAL RLD, RS 2023-02-01 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 94 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213260-001 11369567 2037-06-07 Drug product 2023-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213260-001 11654106 2037-06-07 U-3612 Drug product 2023-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213260-001 11654106 2037-06-07 U-3613 Drug product 2023-06-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213260-001 11925704 2037-06-07 U-3853 Drug product 2024-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213260-001 12168069 2037-06-07 Drug product 2024-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213260-001 12370136 2037-06-07 Drug product 2025-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213260-001 11369567 2037-06-07 Drug product 2023-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213260-001 11654106 2037-06-07 U-3612 Drug product 2023-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213260-001 11654106 2037-06-07 U-3613 Drug product 2023-06-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213260-001 11925704 2037-06-07 U-3853 Drug product 2024-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213260-001 12168069 2037-06-07 Drug product 2024-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213260-001 12370136 2037-06-07 Drug product 2025-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213260-001 11369567 2037-06-07 Drug product 2023-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213260-001 11654106 2037-06-07 U-3612 Drug product 2023-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213260-001 11654106 2037-06-07 U-3613 Drug product 2023-06-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213260-001 11925704 2037-06-07 U-3853 Drug product 2024-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213260-001 12168069 2037-06-07 Drug product 2024-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213260-001 12370136 2037-06-07 Drug product 2025-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213260-001 11369567 2037-06-07 Drug product 2023-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213260-001 11654106 2037-06-07 U-3612 Drug product 2023-06-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213260-001 11654106 2037-06-07 U-3613 Drug product 2023-06-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213260-001 11925704 2037-06-07 U-3853 Drug product 2024-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213260-001 12168069 2037-06-07 Drug product 2024-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213260-001 11369567 2037-06-07 Drug product 2023-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213260-001 11654106 2037-06-07 U-3612 Drug product 2023-06-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213260-001 11654106 2037-06-07 U-3613 Drug product 2023-06-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213260-001 11925704 2037-06-07 U-3853 Drug product 2024-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213260-001 12168069 2037-06-07 Drug product 2024-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213260-001 11369567 2037-06-07 Drug product 2023-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213260-001 11654106 2037-06-07 U-3612 Drug product 2023-06-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213260-001 11654106 2037-06-07 U-3613 Drug product 2023-06-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213260-001 11925704 2037-06-07 U-3853 Drug product 2024-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213260-001 12168069 2037-06-07 Drug product 2024-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213260-001 11369567 2037-06-07 Drug product 2023-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213260-001 11654106 2037-06-07 U-3612 Drug product 2023-06-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213260-001 11654106 2037-06-07 U-3613 Drug product 2023-06-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213260-001 11925704 2037-06-07 U-3853 Drug product 2024-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213260-001 11369567 2037-06-07 Drug product 2023-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213260-001 11654106 2037-06-07 U-3612 Drug product 2023-06-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213260-001 11654106 2037-06-07 U-3613 Drug product 2023-06-01 5bbf6a4d5a75…
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 1 of 1 · 1 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 78238 SUPPL 2024-04-24 78232 SUPPL 2024-04-24 73512 ORIG 2023-02-16 73367 ORIG 2023-02-02 73365 ORIG 2023-02-02