Home Applications 022088 Application 022088
Type NDA
Sponsor PF PRISM CV Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TORISEL TEMSIROLIMUS SOLUTION;INTRAVENOUS 25MG/ML (25MG/ML) 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 N022088-001 TORISEL TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022088-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022088-001 8026276 2026-01-20 Drug product N022088-001 8026276*PED 2026-07-20 Pediatric extension N022088-001 8791097 2032-05-10 U-1550 2014-08-22 N022088-001 8791097 2032-05-10 U-1551 2014-08-22 N022088-001 8791097*PED 2032-11-10 Pediatric extension
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 2 · 41 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 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022088-001 TORISEL 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2007-05-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 10 · 398 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 N022088-001 8026276 2026-01-20 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022088-001 8026276*PED 2026-07-20 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022088-001 8791097 2032-05-10 U-1551 2014-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022088-001 8791097 2032-05-10 U-1550 2014-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022088-001 8791097*PED 2032-11-10 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022088-001 8026276 2026-01-20 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022088-001 8026276*PED 2026-07-20 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022088-001 8791097 2032-05-10 U-1551 2014-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022088-001 8791097 2032-05-10 U-1550 2014-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022088-001 8791097*PED 2032-11-10 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022088-001 8026276 2026-01-20 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022088-001 8026276*PED 2026-07-20 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022088-001 8791097 2032-05-10 U-1551 2014-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022088-001 8791097 2032-05-10 U-1550 2014-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022088-001 8791097*PED 2032-11-10 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022088-001 8026276 2026-01-20 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022088-001 8026276*PED 2026-07-20 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022088-001 8791097 2032-05-10 U-1551 2014-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022088-001 8791097 2032-05-10 U-1550 2014-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022088-001 8791097*PED 2032-11-10 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022088-001 8026276 2026-01-20 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022088-001 8026276*PED 2026-07-20 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022088-001 8791097 2032-05-10 U-1551 2014-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022088-001 8791097 2032-05-10 U-1550 2014-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022088-001 8791097*PED 2032-11-10 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022088-001 8299116*PED 2024-01-25 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022088-001 8455539*PED 2024-01-25 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022088-001 8722700*PED 2024-01-25 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022088-001 8026276 2026-01-20 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022088-001 8026276*PED 2026-07-20 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022088-001 8791097 2032-05-10 U-1551 2014-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022088-001 8791097 2032-05-10 U-1550 2014-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022088-001 8791097*PED 2032-11-10 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022088-001 8299116*PED 2024-01-25 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022088-001 8455539*PED 2024-01-25 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022088-001 8722700*PED 2024-01-25 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022088-001 8026276 2026-01-20 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022088-001 8026276*PED 2026-07-20 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022088-001 8791097 2032-05-10 U-1551 2014-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022088-001 8791097 2032-05-10 U-1550 2014-08-22 2680178bc6a6…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Torisel TEMSIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 95b7dc92-2180-42f1-8699-3c28f609e674 2025-12-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 022088 application number: NDA022088 ndc (product): 0008-1179
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0008-1179 Torisel temsirolimus Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1179 Torisel temsirolimus Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1179 Torisel temsirolimus Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1179 Torisel temsirolimus Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1179 Torisel temsirolimus Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current