Home Applications 213082 Application 213082
Type NDA
Sponsor PFIZER INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XELJANZ TOFACITINIB SOLUTION; ORAL 5MG No No
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 N213082-001 XELJANZ TOFACITINIB CITRATE EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N213082-001 AA
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 N213082-001 RE41783*PED 2026-06-08 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213082-001 M-14 2028-02-21 N213082-001 PED 2028-08-21
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 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL RLD, RS 2020-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213082-001 Xeljanz EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213082-001 Xeljanz EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213082-001 Xeljanz EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213082-001 XELJANZ EQ 1MG/ML BASE SOLUTION / ORAL RLD, RS 2020-09-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213082-001 XELJANZ EQ 1MG BASE/ML SOLUTION / ORAL AA RLD, RS 2020-09-25 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 48 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 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213082-001 RE41783*PED 2026-06-08 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213082-001 RE41783*PED 2026-06-08 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213082-001 RE41783*PED 2026-06-08 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213082-001 RE41783*PED 2026-06-08 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213082-001 6956041 2020-12-08 Drug product 2020-10-22 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N213082-001 7265221 2020-12-08 Drug substance 2020-10-22 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N213082-001 7301023 2020-12-08 Drug substance 2020-10-22 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N213082-001 6956041 2020-12-08 Drug product 2020-10-22 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N213082-001 7265221 2020-12-08 Drug substance 2020-10-22 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N213082-001 7301023 2020-12-08 Drug substance 2020-10-22 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213082-001 RE41783 2025-12-08 Drug substance 2020-10-22 3f0d92c62455…
Observed Orange Book exclusivity history# 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-1029 XELJANZ tofacitinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-1029 XELJANZ tofacitinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-1029 XELJANZ tofacitinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-1029 XELJANZ tofacitinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-1029 XELJANZ tofacitinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-1029 XELJANZ tofacitinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-1029 XELJANZ tofacitinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-1029 XELJANZ tofacitinib Pfizer Laboratories Div Pfizer Inc NDA Current 0069-1029 XELJANZ tofacitinib Pfizer Laboratories Div Pfizer Inc NDA Current