Home Applications 217933 Application 217933
Type NDA
Sponsor BTG INTL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AURLUMYN ILOPROST SOLUTION;INTRAVENOUS 100MCG/ML (100MCG/ML) 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 N217933-001 AURLUMYN ILOPROST 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217933-001 12409184 2041-08-06 Drug product 2025-09-19 N217933-001 12409183 2044-07-18 U-4263 2025-09-19
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217933-001 NP 2027-02-13 N217933-001 ODE-465 2031-02-13
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.
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 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217933-001 AURLUMYN 100MCG/ML (100MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-02-13 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N217933-001 12409184 2041-08-06 Drug product 2025-09-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217933-001 12409183 2044-07-18 U-4263 2025-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217933-001 12409184 2041-08-06 Drug product 2025-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217933-001 12409183 2044-07-18 U-4263 2025-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217933-001 12409184 2041-08-06 Drug product 2025-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217933-001 12409183 2044-07-18 U-4263 2025-09-19 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217933-001 12409184 2041-08-06 Drug product 2025-09-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217933-001 12409183 2044-07-18 U-4263 2025-09-19 a50c72e98297…
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 AURLUMYN ILOPROST BTG International Inc 34036fc0-6832-d066-e063-6394a90a18a4 2026-08-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 217933 application number: NDA217933
Documents# Document, Submission type, Date table Document Submission type Date 80910 ORIG 2025-02-04 78508 SUPPL 2024-05-20 78484 SUPPL 2024-05-15 77503 ORIG 2024-02-15 77496 ORIG 2024-02-14