Home Applications 205437 Application 205437
Type NDA
Sponsor AMGEN INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OTEZLA APREMILAST TABLET;ORAL 10MG Yes No 002 OTEZLA APREMILAST TABLET;ORAL 20MG Yes No 003 OTEZLA APREMILAST TABLET;ORAL 30MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205437-001 OTEZLA APREMILAST 10MG TABLET / ORAL AB RLD 2014-03-21 N205437-002 OTEZLA APREMILAST 20MG TABLET / ORAL AB RLD 2014-03-21 N205437-003 OTEZLA APREMILAST 30MG TABLET / ORAL AB RLD, RS 2014-03-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 36 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205437-001 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 N205437-001 7427638*PED 2028-08-16 Pediatric extension N205437-001 12576034 2033-11-30 U-1858 Drug product 2026-04-16 N205437-001 12576034 2033-11-30 U-4290 Drug product 2026-04-16 N205437-001 12576034 2033-11-30 U-4291 Drug product 2026-04-16 N205437-001 10092541 2034-05-29 U-2403 2018-10-09 N205437-001 10092541 2034-05-29 U-2659 2018-10-09 N205437-001 9872854 2034-05-29 U-2232 2018-02-21 N205437-001 9872854 2034-05-29 U-2233 2018-02-21 N205437-001 12576034*PED 2034-05-30 Pediatric extension N205437-001 10092541*PED 2034-11-29 Pediatric extension N205437-001 9872854*PED 2034-11-29 Pediatric extension N205437-002 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 N205437-002 7427638*PED 2028-08-16 Pediatric extension N205437-002 12576034 2033-11-30 U-1858 Drug product 2026-04-16 N205437-002 12576034 2033-11-30 U-4290 Drug product 2026-04-16 N205437-002 12576034 2033-11-30 U-4291 Drug product 2026-04-16 N205437-002 10092541 2034-05-29 U-2403 2018-10-09 N205437-002 10092541 2034-05-29 U-2659 2018-10-09 N205437-002 9872854 2034-05-29 U-2232 2018-02-21 N205437-002 9872854 2034-05-29 U-2233 2018-02-21 N205437-002 12576034*PED 2034-05-30 Pediatric extension N205437-002 10092541*PED 2034-11-29 Pediatric extension N205437-002 9872854*PED 2034-11-29 Pediatric extension N205437-003 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 N205437-003 7427638*PED 2028-08-16 Pediatric extension N205437-003 12576034 2033-11-30 U-1858 Drug product 2026-04-16 N205437-003 12576034 2033-11-30 U-4290 Drug product 2026-04-16 N205437-003 12576034 2033-11-30 U-4291 Drug product 2026-04-16 N205437-003 10092541 2034-05-29 U-2403 2018-10-09 N205437-003 10092541 2034-05-29 U-2659 2018-10-09 N205437-003 9872854 2034-05-29 U-2232 2018-02-21 N205437-003 9872854 2034-05-29 U-2233 2018-02-21 N205437-003 12576034*PED 2034-05-30 Pediatric extension N205437-003 10092541*PED 2034-11-29 Pediatric extension N205437-003 9872854*PED 2034-11-29 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 18 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 4 · 123 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 2026-02-19 14:30 UTC 2026-02 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205437-002 OTEZLA 20MG TABLET / ORAL AB RLD 2014-03-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205437-003 OTEZLA 30MG TABLET / ORAL AB RLD, RS 2014-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205437-001 OTEZLA 10MG TABLET / ORAL AB RLD 2014-03-21 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 102 observed states.
Observed Orange Book patent history# Patent history page 1 of 61 · 2,436 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 N205437-001 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 7427638*PED 2028-08-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 10092541 2034-05-29 U-2403 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 10092541 2034-05-29 U-2659 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 9872854 2034-05-29 U-2232 2018-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 9872854 2034-05-29 U-2233 2018-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 10092541*PED 2034-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-001 9872854*PED 2034-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 7427638*PED 2028-08-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 10092541 2034-05-29 U-2659 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 10092541 2034-05-29 U-2403 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 9872854 2034-05-29 U-2232 2018-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 9872854 2034-05-29 U-2233 2018-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 10092541*PED 2034-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-002 9872854*PED 2034-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 7427638*PED 2028-08-16 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 10092541 2034-05-29 U-2403 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 10092541 2034-05-29 U-2659 2018-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 9872854 2034-05-29 U-2232 2018-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 9872854 2034-05-29 U-2233 2018-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 10092541*PED 2034-11-29 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205437-003 9872854*PED 2034-11-29 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 7427638*PED 2028-08-16 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 10092541 2034-05-29 U-2403 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 10092541 2034-05-29 U-2659 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 9872854 2034-05-29 U-2232 2018-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 9872854 2034-05-29 U-2233 2018-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 10092541*PED 2034-11-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-001 9872854*PED 2034-11-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 7427638 2028-02-16 Drug substance, Drug product 2014-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 7427638*PED 2028-08-16 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 10092541 2034-05-29 U-2659 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 10092541 2034-05-29 U-2403 2018-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 9872854 2034-05-29 U-2232 2018-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 9872854 2034-05-29 U-2233 2018-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 10092541*PED 2034-11-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205437-002 9872854*PED 2034-11-29 Pediatric extension 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 14 · 549 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 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 44 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55513-137 Otezla apremilast Amgen Inc NDA Current 55513-137 Otezla apremilast Amgen Inc NDA Current 55513-137 Otezla apremilast Amgen Inc NDA Current 55513-137 Otezla apremilast Amgen Inc NDA Current 55513-137 Otezla apremilast Amgen Inc NDA Current 55513-137 Otezla apremilast Amgen Inc NDA Current 55513-137 Otezla apremilast Amgen Inc NDA Current 55513-137 Otezla apremilast Amgen Inc NDA Current 55513-137 Otezla apremilast Amgen Inc NDA Current 55513-137 Otezla apremilast Amgen Inc NDA Current 55513-369 Otezla apremilast Amgen Inc NDA Current 55513-369 Otezla apremilast Amgen Inc NDA Current 55513-369 Otezla apremilast Amgen Inc NDA Current 55513-369 Otezla apremilast Amgen Inc NDA Current 55513-369 Otezla apremilast Amgen Inc NDA Current 55513-369 Otezla apremilast Amgen Inc NDA Current 55513-369 Otezla apremilast Amgen Inc NDA Current 55513-369 Otezla apremilast Amgen Inc NDA Current 55513-369 Otezla apremilast Amgen Inc NDA Current 55513-369 Otezla apremilast Amgen Inc NDA Current 55513-485 Otezla apremilast Amgen Inc NDA Current 55513-485 Otezla apremilast Amgen Inc NDA Current 55513-485 Otezla apremilast Amgen Inc NDA Current 55513-485 Otezla apremilast Amgen Inc NDA Current 55513-485 Otezla apremilast Amgen Inc NDA Current 55513-485 Otezla apremilast Amgen Inc NDA Current 55513-485 Otezla apremilast Amgen Inc NDA Current 55513-485 Otezla apremilast Amgen Inc NDA Current 55513-485 Otezla apremilast Amgen Inc NDA Current 55513-485 Otezla apremilast Amgen Inc NDA Current 59572-630 OTEZLA apremilast Celgene Corporation NDA Current 59572-630 OTEZLA apremilast Celgene Corporation NDA Current 59572-630 OTEZLA apremilast Celgene Corporation NDA Current 59572-630 OTEZLA apremilast Celgene Corporation NDA Current 59572-631 OTEZLA apremilast Celgene Corporation NDA Current 59572-631 OTEZLA apremilast Celgene Corporation NDA Current 59572-631 OTEZLA apremilast Celgene Corporation NDA Current 59572-631 OTEZLA apremilast Celgene Corporation NDA Current 59572-632 OTEZLA apremilast Celgene Corporation NDA Current 59572-632 OTEZLA apremilast Celgene Corporation NDA Current 59572-632 OTEZLA apremilast Celgene Corporation NDA Current 59572-632 OTEZLA apremilast Celgene Corporation NDA Current 70518-3155 Otezla apremilast REMEDYREPACK INC. NDA Current 70518-3155 Otezla apremilast REMEDYREPACK INC. NDA Current