Home Applications 020444 Application 020444
Type NDA
Sponsor GLAXOSMITHKLINE LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FLOLAN EPOPROSTENOL SODIUM INJECTABLE;INJECTION EQ 0.5MG BASE/VIAL Yes Yes 002 FLOLAN EPOPROSTENOL SODIUM INJECTABLE;INJECTION EQ 1.5MG BASE/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N020444-001 FLOLAN EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION RLD 1995-09-20 N020444-002 FLOLAN EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION RLD 1995-09-20
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 3 · 86 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 2026-09-14 22:38:34 2026-08 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION RLD 1995-09-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION RLD 1995-09-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION RLD 1995-09-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION RLD 1995-09-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION RLD 1995-09-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION RLD 1995-09-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP1 RLD, RS 1995-09-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020444-001 FLOLAN EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-09-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020444-002 FLOLAN EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1995-09-20 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 78 observed states.
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 · 22 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0173-0517 FLOLAN epoprostenol sodium GlaxoSmithKline LLC NDA Current 0173-0517 FLOLAN epoprostenol sodium GlaxoSmithKline LLC NDA Current 0173-0517 FLOLAN epoprostenol sodium GlaxoSmithKline LLC NDA Current 0173-0517 FLOLAN epoprostenol sodium GlaxoSmithKline LLC NDA Current 0173-0517 FLOLAN epoprostenol sodium GlaxoSmithKline LLC NDA Current 0173-0517 FLOLAN epoprostenol sodium GlaxoSmithKline LLC NDA Current 0173-0518 Diluent water GlaxoSmithKline LLC NDA Current 0173-0518 Diluent water GlaxoSmithKline LLC NDA Current 0173-0518 Diluent water GlaxoSmithKline LLC NDA Current 0173-0518 Diluent water GlaxoSmithKline LLC NDA Current 0173-0519 FLOLAN epoprostenol sodium GlaxoSmithKline LLC NDA Current 0173-0519 FLOLAN epoprostenol sodium GlaxoSmithKline LLC NDA Current 0173-0519 FLOLAN epoprostenol sodium GlaxoSmithKline LLC NDA Current 0173-0519 FLOLAN epoprostenol sodium GlaxoSmithKline LLC NDA Current 0173-0519 FLOLAN epoprostenol sodium GlaxoSmithKline LLC NDA Current 0173-0519 FLOLAN epoprostenol sodium GlaxoSmithKline LLC NDA Current 0173-0857 Diluent water GlaxoSmithKline LLC NDA Current 0173-0857 Diluent water GlaxoSmithKline LLC NDA Current 0173-0857 Diluent water GlaxoSmithKline LLC NDA Current 0173-0857 Diluent water GlaxoSmithKline LLC NDA Current 0173-0857 Diluent water GlaxoSmithKline LLC NDA Current 0173-0857 Diluent water GlaxoSmithKline LLC NDA Current