Home Applications 213871 Application 213871
Type NDA
Sponsor PFIZER INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CIBINQO ABROCITINIB TABLET;ORAL 50MG Yes No 002 CIBINQO ABROCITINIB TABLET;ORAL 100MG Yes No 003 CIBINQO ABROCITINIB TABLET; ORAL 200MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N213871-001 CIBINQO ABROCITINIB 50MG TABLET / ORAL RLD 2022-01-14 N213871-002 CIBINQO ABROCITINIB 100MG TABLET / ORAL RLD 2022-01-14 N213871-003 CIBINQO ABROCITINIB 200MG TABLET / ORAL RLD, RS 2022-01-14
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213871-001 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 N213871-001 9549929 2034-02-19 U-3195 2022-02-11 N213871-001 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 N213871-002 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 N213871-002 9549929 2034-02-19 U-3195 2022-02-11 N213871-002 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 N213871-003 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 N213871-003 9549929 2034-02-19 U-3195 2022-02-11 N213871-003 9035074 2036-01-14 Drug substance, Drug product 2022-02-11
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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 3 · 105 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 2026-10-15 13:18:30 2026-09 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 c2088c7a36db…2026-09-14 22:38:34 2026-08 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213871-002 CIBINQO 100MG TABLET / ORAL RLD 2022-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213871-003 CIBINQO 200MG TABLET / ORAL RLD, RS 2022-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213871-001 CIBINQO 50MG TABLET / ORAL RLD 2022-01-14 79d66fd596c7…
Observed Orange Book patent history# Patent history page 1 of 8 · 306 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 N213871-001 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213871-001 9549929 2034-02-19 U-3195 2022-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213871-001 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213871-002 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213871-002 9549929 2034-02-19 U-3195 2022-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213871-002 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213871-003 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213871-003 9549929 2034-02-19 U-3195 2022-02-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213871-003 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 N213871-001 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213871-001 9549929 2034-02-19 U-3195 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213871-001 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213871-002 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213871-002 9549929 2034-02-19 U-3195 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213871-002 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213871-003 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213871-003 9549929 2034-02-19 U-3195 2022-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213871-003 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213871-001 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213871-001 9549929 2034-02-19 U-3195 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213871-001 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213871-002 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213871-002 9549929 2034-02-19 U-3195 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213871-002 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213871-003 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213871-003 9549929 2034-02-19 U-3195 2022-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213871-003 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213871-001 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-001 9549929 2034-02-19 U-3195 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-001 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-002 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-002 9549929 2034-02-19 U-3195 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-002 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-003 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-003 9549929 2034-02-19 U-3195 2022-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213871-003 9035074 2036-01-14 Drug substance, Drug product 2022-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-001 9035074 2034-02-19 Drug substance, Drug product 2022-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-001 9545405 2034-02-19 Drug substance, Drug product 2022-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-001 9549929 2034-02-19 U-3195 2022-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213871-002 9035074 2034-02-19 Drug substance, Drug product 2022-02-11 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 180 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.
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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-0235 Cibinqo abrocitinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0335 Cibinqo abrocitinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-0435 Cibinqo abrocitinib Pfizer Laboratories Div Pfizer Inc NDA Current 63539-236 CIBINQO abrocitinib U.S. Pharmaceuticals NDA Current 63539-336 CIBINQO abrocitinib U.S. Pharmaceuticals NDA Current 63539-436 CIBINQO abrocitinib U.S. Pharmaceuticals NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 76861 SUPPL 2023-12-15 76843 SUPPL 2023-12-15 76842 SUPPL 2023-12-15 73450 SUPPL 2023-02-10 73448 SUPPL 2023-02-10 70139 ORIG 2022-02-10 69921 ORIG 2022-01-19 69920 ORIG 2022-01-19 69899 ORIG 2022-01-19