Home Applications 020049 Application 020049
Type NDA
Sponsor SHIRE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PENTASA MESALAMINE CAPSULE, EXTENDED RELEASE;ORAL 250MG Yes No 002 PENTASA MESALAMINE CAPSULE, EXTENDED RELEASE;ORAL 500MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020049-001 PENTASA MESALAMINE 250MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 1993-05-10 N020049-002 PENTASA MESALAMINE 500MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2004-07-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 of 3 · 88 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 2022-10-28 04:53 UTC 2022-10 N020049-001 PENTASA 250MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1993-05-10 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020049-002 PENTASA 500MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2004-07-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020049-001 PENTASA 250MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1993-05-10 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020049-002 PENTASA 500MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2004-07-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020049-001 PENTASA 250MG CAPSULE, EXTENDED RELEASE / ORAL RLD 1993-05-10 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020049-002 PENTASA 500MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2004-07-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020049-001 PENTASA 250MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD 1993-05-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020049-002 PENTASA 500MG CAPSULE, EXTENDED RELEASE / ORAL AB RLD, RS 2004-07-08 a50c72e98297…
Observed Orange Book normalized TE 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 · 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 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 54092-189 Pentasa mesalamine Takeda Pharmaceuticals America, Inc. NDA Current 54092-189 Pentasa mesalamine Takeda Pharmaceuticals America, Inc. NDA Current 54092-189 Pentasa mesalamine Shire US Manufacturing Inc. NDA Current 54092-189 Pentasa mesalamine Shire US Manufacturing Inc. NDA Current 54092-189 Pentasa mesalamine Takeda Pharmaceuticals America, Inc. NDA Current 54092-189 Pentasa mesalamine Takeda Pharmaceuticals America, Inc. NDA Current 54092-189 Pentasa mesalamine Takeda Pharmaceuticals America, Inc. NDA Current 54092-189 Pentasa mesalamine Takeda Pharmaceuticals America, Inc. NDA Current 54092-191 Pentasa mesalamine Takeda Pharmaceuticals America, Inc. NDA Current 54092-191 Pentasa mesalamine Takeda Pharmaceuticals America, Inc. NDA Current 54092-191 Pentasa mesalamine Shire US Manufacturing Inc. NDA Current 54092-191 Pentasa mesalamine Shire US Manufacturing Inc. NDA Current 54092-191 Pentasa mesalamine Takeda Pharmaceuticals America, Inc. NDA Current 54092-191 Pentasa mesalamine Takeda Pharmaceuticals America, Inc. NDA Current 54092-191 Pentasa mesalamine Takeda Pharmaceuticals America, Inc. NDA Current 54092-191 Pentasa mesalamine Takeda Pharmaceuticals America, Inc. NDA Current 68151-4769 Pentasa mesalamine Carilion Materials Management NDA Current 69189-0189 Pentasa mesalamine Avera McKennan Hospital NDA Current