Home Applications 020193 Application 020193
Type NDA
Sponsor JANSSEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ELMIRON PENTOSAN POLYSULFATE SODIUM CAPSULE;ORAL 100MG 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 N020193-001 ELMIRON PENTOSAN POLYSULFATE SODIUM 100MG CAPSULE / ORAL RLD, RS 1996-09-26
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 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020193-001 ELMIRON 100MG CAPSULE / ORAL RLD, RS 1996-09-26 cb3db0bc1861…
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 ELMIRON PENTOSAN POLYSULFATE SODIUM Janssen Pharmaceuticals, Inc. f0ba651e-3d8a-11df-8fbe-119855d89593 2024-09-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 020193 application number: NDA020193 ndc (product): 50458-098
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 50458-098 ELMIRON PENTOSAN POLYSULFATE SODIUM Janssen Pharmaceuticals, Inc. NDA Current 50458-098 ELMIRON PENTOSAN POLYSULFATE SODIUM Janssen Pharmaceuticals, Inc. NDA Current 50458-098 ELMIRON PENTOSAN POLYSULFATE SODIUM Janssen Pharmaceuticals, Inc. NDA Current 50458-098 ELMIRON PENTOSAN POLYSULFATE SODIUM Janssen Pharmaceuticals, Inc. NDA Current 50458-098 ELMIRON PENTOSAN POLYSULFATE SODIUM Janssen Pharmaceuticals, Inc. NDA Current