Home NDC 0007-4643 PROMACTA
Product NDC 0007-4643
11-digit product format 000074643
Labeler code 0007
Product ID 0007-4643_c7c46a73-1f77-45f6-ab60-1aa8f9e87463
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eltrombopag olamine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler GlaxoSmithKline LLC
Application NDA022291
Marketing category NDA
Marketing start 2012-01-02
Marketing end 2019-04-30
Substance ELTROMBOPAG OLAMINE
Active strength 13 mg/1
Pharmacologic classes Increased Megakaryocyte Maturation [PE],Increased Platelet Production [PE],Thrombopoietin Receptor Agonist [EPC],Thrombopoietin Receptor Agonists [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],UGT1A1 Inhibitors [MoA],UGT1A3 Inhibitors [MoA],UGT1A4 Inhibitors [MoA],UGT1A6 Inhibitors [MoA],UGT1A9 Inhibitors [MoA],UGT2B7 Inhibitors [MoA],UGT2B15 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0007-4643-13 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0007-4643-13 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0007-4643-13 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0007-4643-13 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0007-4643-13 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0007-4643-13 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0007-4643-13 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0007-4643-13 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0007-4643-13 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0007-4643-13 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0007-4643-13 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0007-4643-13 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022291-001 PROMACTA ELTROMBOPAG OLAMINE EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 N022291-002 PROMACTA ELTROMBOPAG OLAMINE EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 N022291-003 PROMACTA ELTROMBOPAG OLAMINE EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 N022291-004 PROMACTA ELTROMBOPAG OLAMINE EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 N022291-005 PROMACTA ELTROMBOPAG OLAMINE EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 79 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022291-001 7547719 2025-07-13 U-1306 Drug substance, Drug product N022291-001 7547719 2025-07-13 U-1575 Drug substance, Drug product N022291-001 7547719 2025-07-13 U-2451 Drug substance, Drug product N022291-001 7547719 2025-07-13 U-2452 Drug substance, Drug product N022291-001 7547719*PED 2026-01-13 Pediatric extension N022291-001 8052993 2027-08-01 U-1306 Drug product 2011-12-07 N022291-001 8052993 2027-08-01 U-1575 Drug product 2011-12-07 N022291-001 8052993 2027-08-01 U-2451 Drug product 2011-12-07 N022291-001 8052993 2027-08-01 U-930 Drug product 2011-12-07 N022291-001 8052994 2027-08-01 U-1714 Drug product 2015-07-10 N022291-001 8062665 2027-08-01 U-1714 Drug product 2015-07-10 N022291-001 8071129 2027-08-01 U-1714 Drug product 2015-07-10 N022291-001 8828430 2027-08-01 U-1306 Drug product 2014-10-07 N022291-001 8828430 2027-08-01 U-2451 Drug product 2014-10-07 N022291-001 8052993*PED 2028-02-01 Pediatric extension N022291-001 8052994*PED 2028-02-01 Pediatric extension N022291-001 8062665*PED 2028-02-01 Pediatric extension N022291-001 8071129*PED 2028-02-01 Pediatric extension N022291-001 8828430*PED 2028-02-01 Pediatric extension N022291-002 7547719 2025-07-13 U-1306 Drug substance, Drug product N022291-002 7547719 2025-07-13 U-1575 Drug substance, Drug product N022291-002 7547719 2025-07-13 U-2451 Drug substance, Drug product N022291-002 7547719 2025-07-13 U-2452 Drug substance, Drug product N022291-002 7547719 2025-07-13 U-930 Drug substance, Drug product N022291-002 7547719*PED 2026-01-13 Pediatric extension N022291-002 8052993 2027-08-01 U-1714 Drug product 2015-07-10 N022291-002 8052994 2027-08-01 U-1306 Drug product 2011-12-07 N022291-002 8052994 2027-08-01 U-2451 Drug product 2011-12-07 N022291-002 8052994 2027-08-01 U-930 Drug product 2011-12-07 N022291-002 8062665 2027-08-01 U-1714 Drug product 2015-07-10 N022291-002 8071129 2027-08-01 U-1714 Drug product 2015-07-10 N022291-002 8828430 2027-08-01 U-1306 Drug product 2014-10-07 N022291-002 8828430 2027-08-01 U-2451 Drug product 2014-10-07 N022291-002 8052993*PED 2028-02-01 Pediatric extension N022291-002 8052994*PED 2028-02-01 Pediatric extension N022291-002 8062665*PED 2028-02-01 Pediatric extension N022291-002 8071129*PED 2028-02-01 Pediatric extension N022291-002 8828430*PED 2028-02-01 Pediatric extension N022291-003 7547719 2025-07-13 U-1306 Drug substance, Drug product N022291-003 7547719 2025-07-13 U-1575 Drug substance, Drug product N022291-003 7547719 2025-07-13 U-2451 Drug substance, Drug product N022291-003 7547719 2025-07-13 U-2452 Drug substance, Drug product N022291-003 7547719 2025-07-13 U-930 Drug substance, Drug product N022291-003 7547719*PED 2026-01-13 Pediatric extension N022291-003 8052993 2027-08-01 U-1714 Drug product 2015-07-10 N022291-003 8052994 2027-08-01 U-1714 Drug product 2015-07-10 N022291-003 8062665 2027-08-01 U-1306 Drug product 2011-12-07 N022291-003 8062665 2027-08-01 U-2451 Drug product 2011-12-07 N022291-003 8062665 2027-08-01 U-930 Drug product 2011-12-07 N022291-003 8071129 2027-08-01 U-1714 Drug product 2015-07-10 N022291-003 8828430 2027-08-01 U-1306 Drug product 2014-10-07 N022291-003 8828430 2027-08-01 U-2451 Drug product 2014-10-07 N022291-003 8052993*PED 2028-02-01 Pediatric extension N022291-003 8052994*PED 2028-02-01 Pediatric extension N022291-003 8062665*PED 2028-02-01 Pediatric extension N022291-003 8071129*PED 2028-02-01 Pediatric extension N022291-003 8828430*PED 2028-02-01 Pediatric extension N022291-004 7547719 2025-07-13 U-1306 Drug substance, Drug product N022291-004 7547719 2025-07-13 U-1575 Drug substance, Drug product N022291-004 7547719 2025-07-13 U-2451 Drug substance, Drug product N022291-004 7547719 2025-07-13 U-2452 Drug substance, Drug product N022291-004 7547719*PED 2026-01-13 Pediatric extension N022291-004 8052993 2027-08-01 U-1714 Drug product 2015-07-10 N022291-004 8052994 2027-08-01 U-1714 Drug product 2015-07-10 N022291-004 8062665 2027-08-01 U-1714 Drug product 2015-07-10 N022291-004 8071129 2027-08-01 U-1306 Drug product 2011-12-21 N022291-004 8071129 2027-08-01 U-2451 Drug product 2011-12-21 N022291-004 8071129 2027-08-01 U-930 Drug product 2011-12-21 N022291-004 8828430 2027-08-01 U-1306 Drug product 2014-10-07 N022291-004 8828430 2027-08-01 U-2451 Drug product 2014-10-07 N022291-004 8052993*PED 2028-02-01 Pediatric extension N022291-004 8052994*PED 2028-02-01 Pediatric extension N022291-004 8062665*PED 2028-02-01 Pediatric extension N022291-004 8071129*PED 2028-02-01 Pediatric extension N022291-004 8828430*PED 2028-02-01 Pediatric extension N022291-005 7547719 2025-07-13 U-1306 Drug substance, Drug product N022291-005 7547719 2025-07-13 U-1575 Drug substance, Drug product N022291-005 7547719 2025-07-13 U-930 Drug substance, Drug product N022291-005 7547719*PED 2026-01-13 Pediatric extension
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 6 · 205 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 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-005 PROMACTA EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-005 PROMACTA EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-005 PROMACTA EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-005 PROMACTA EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-005 PROMACTA EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL RLD 2008-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL RLD 2008-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL RLD, RS 2009-09-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL RLD 2011-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-005 PROMACTA EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL RLD 2008-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL RLD 2008-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL RLD, RS 2009-09-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL RLD 2011-10-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-005 PROMACTA EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL RLD 2008-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL RLD 2008-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL RLD, RS 2009-09-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL RLD 2011-10-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-005 PROMACTA EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 115 · 4,567 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022291-001 7547719 2025-07-13 U-2451 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 7547719 2025-07-13 U-2452 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 7547719 2025-07-13 U-1575 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 7547719 2025-07-13 U-1306 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 7547719*PED 2026-01-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8052993 2027-08-01 U-1306 Drug product 2011-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8052993 2027-08-01 U-2451 Drug product 2011-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8052993 2027-08-01 U-930 Drug product 2011-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8052993 2027-08-01 U-1575 Drug product 2011-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8052994 2027-08-01 U-1714 Drug product 2015-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8062665 2027-08-01 U-1714 Drug product 2015-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8071129 2027-08-01 U-1714 Drug product 2015-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8828430 2027-08-01 U-2451 Drug product 2014-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8828430 2027-08-01 U-1306 Drug product 2014-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8052993*PED 2028-02-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8052994*PED 2028-02-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8062665*PED 2028-02-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8071129*PED 2028-02-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-001 8828430*PED 2028-02-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 7547719 2025-07-13 U-1575 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 7547719 2025-07-13 U-2452 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 7547719 2025-07-13 U-1306 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 7547719 2025-07-13 U-930 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 7547719 2025-07-13 U-2451 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 7547719*PED 2026-01-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 8052993 2027-08-01 U-1714 Drug product 2015-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 8052994 2027-08-01 U-1306 Drug product 2011-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 8052994 2027-08-01 U-2451 Drug product 2011-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 8052994 2027-08-01 U-930 Drug product 2011-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 8062665 2027-08-01 U-1714 Drug product 2015-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 8071129 2027-08-01 U-1714 Drug product 2015-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 8828430 2027-08-01 U-2451 Drug product 2014-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 8828430 2027-08-01 U-1306 Drug product 2014-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 8052993*PED 2028-02-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 8052994*PED 2028-02-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 8062665*PED 2028-02-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 8071129*PED 2028-02-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-002 8828430*PED 2028-02-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-003 7547719 2025-07-13 U-2451 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022291-003 7547719 2025-07-13 U-1575 Drug substance, Drug product 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 9 · 330 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-001 ODE-210 2025-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-002 ODE-210 2025-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-003 ODE-210 2025-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-004 ODE-210 2025-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022291-005 ODE-210 2025-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022291-001 ODE-210 2025-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-002 ODE-210 2025-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-003 ODE-210 2025-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-004 ODE-210 2025-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022291-005 ODE-210 2025-11-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-001 ODE-210 2025-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-002 ODE-210 2025-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-003 ODE-210 2025-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-004 ODE-210 2025-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022291-005 ODE-210 2025-11-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-001 ODE-210 2025-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-002 ODE-210 2025-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-003 ODE-210 2025-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-004 ODE-210 2025-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022291-005 ODE-210 2025-11-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-001 ODE-210 2025-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-002 ODE-210 2025-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-003 ODE-210 2025-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-004 ODE-210 2025-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022291-005 ODE-210 2025-11-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-001 ODE-210 2025-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-002 ODE-210 2025-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-003 ODE-210 2025-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-004 ODE-210 2025-11-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022291-005 ODE-210 2025-11-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-001 ODE-210 2025-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-002 ODE-210 2025-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-003 ODE-210 2025-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-004 ODE-210 2025-11-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022291-005 ODE-210 2025-11-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-001 ODE-210 2025-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-002 ODE-210 2025-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-003 ODE-210 2025-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-004 ODE-210 2025-11-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022291-005 ODE-210 2025-11-16 d8e5a09893c0…
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 PROMACTA ELTROMBOPAG OLAMINE Novartis Pharmaceuticals Corporation 7714a0ed-34bb-46e6-a0a5-b363908b22c2 2025-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022291 application number: NDA022291