Home Applications 019600 Application 019600
Type NDA
Sponsor BAUSCH Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OXSORALEN-ULTRA METHOXSALEN CAPSULE;ORAL 10MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N019600-001 OXSORALEN-ULTRA METHOXSALEN 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019600-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019600-001 OXSORALEN-ULTRA 10MG CAPSULE / ORAL AB RLD, RS 1986-10-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0187-0650 Oxsoralen-Ultra Methoxsalen Bausch Health US, LLC NDA Current 0187-0650 Oxsoralen-Ultra Methoxsalen Valeant Pharmaceuticals North America LLC NDA Current 0187-0650 Oxsoralen-Ultra Methoxsalen Bausch Health Americas, Inc. NDA Current 68682-065 Methoxsalen Methoxsalen Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 1415 SUPPL 2003-04-15 1414 SUPPL 2003-04-15 11560 SUPPL 2003-03-28 11559 SUPPL 2003-03-26