Home Applications 021110 Application 021110
Type NDA
Sponsor PF PRISM CV Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RAPAMUNE SIROLIMUS TABLET;ORAL 1MG Yes No 002 RAPAMUNE SIROLIMUS TABLET;ORAL 2MG Yes Yes 003 RAPAMUNE SIROLIMUS TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 004 RAPAMUNE SIROLIMUS TABLET;ORAL 0.5MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021110-001 RAPAMUNE SIROLIMUS 1MG TABLET / ORAL AB RLD 2000-08-25 N021110-002 RAPAMUNE SIROLIMUS 2MG TABLET / ORAL AB RLD, RS 2002-08-22 N021110-003 RAPAMUNE SIROLIMUS 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 N021110-004 RAPAMUNE SIROLIMUS 0.5MG TABLET / ORAL AB RLD 2010-01-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 5 · 164 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 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 72 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 · 42 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0008-1040 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1040 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1040 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1040 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1040 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1040 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1040 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1040 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1040 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1040 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1041 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1041 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1041 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1041 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1041 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1041 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1041 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1041 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1041 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1041 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1042 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1042 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1042 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1042 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1042 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1042 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1042 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1042 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1042 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 0008-1042 Rapamune SIROLIMUS Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. NDA Current 59762-1001 Sirolimus SIROLIMUS Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1001 Sirolimus SIROLIMUS Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1001 Sirolimus SIROLIMUS Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1001 Sirolimus SIROLIMUS Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1002 Sirolimus SIROLIMUS Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1002 Sirolimus SIROLIMUS Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1002 Sirolimus SIROLIMUS Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1002 Sirolimus SIROLIMUS Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1003 Sirolimus SIROLIMUS Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1003 Sirolimus SIROLIMUS Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1003 Sirolimus SIROLIMUS Greenstone LLC NDA AUTHORIZED GENERIC Current 59762-1003 Sirolimus SIROLIMUS Greenstone LLC NDA AUTHORIZED GENERIC Current