Home Applications 208630 Application 208630
Type NDA
Sponsor NXDC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GLEOLAN AMINOLEVULINIC ACID HYDROCHLORIDE FOR SOLUTION;ORAL 1.5GM/VIAL 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 N208630-001 GLEOLAN AMINOLEVULINIC ACID HYDROCHLORIDE 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06
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 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208630-001 GLEOLAN 1.5GM/VIAL FOR SOLUTION / ORAL RLD, RS 2017-06-06 e64feba35796…
Observed Orange Book exclusivity 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GLEOLAN AMINOLEVULINIC ACID HYDROCHLORIDE NX DEVELOPMENT CORP cdeded66-0017-42cf-9471-13f231014323 2026-01-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 208630 application number: NDA208630 ndc (product): 71469-231
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59137-231 GLEOLAN AMINOLEVULINIC ACID HYDROCHLORIDE Medexus Pharma, Inc. NDA Current 71469-231 GLEOLAN AMINOLEVULINIC ACID HYDROCHLORIDE NX DEVELOPMENT CORP NDA Current 71469-231 GLEOLAN AMINOLEVULINIC ACID HYDROCHLORIDE NX DEVELOPMENT CORP NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 78237 SUPPL 2024-04-24 78233 SUPPL 2024-04-24 58045 SUPPL 2019-03-20 55314 SUPPL 2018-08-24 55277 SUPPL 2018-08-23 55135 ORIG 2018-08-08 54663 SUPPL 2018-06-21 54600 SUPPL 2018-06-14 48663 ORIG 2017-06-07 48662 ORIG 2017-06-07