Home Applications 022291 Application 022291
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROMACTA ELTROMBOPAG OLAMINE TABLET;ORAL EQ 25MG ACID Yes No 002 PROMACTA ELTROMBOPAG OLAMINE TABLET;ORAL EQ 50MG ACID Yes No 003 PROMACTA ELTROMBOPAG OLAMINE TABLET;ORAL EQ 75MG ACID Yes Yes 004 PROMACTA ELTROMBOPAG OLAMINE TABLET;ORAL EQ 12.5MG ACID Yes No 005 PROMACTA ELTROMBOPAG OLAMINE TABLET;ORAL EQ 100MG ACID Yes No
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PROMACTA ELTROMBOPAG OLAMINE EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16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# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 · 44 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0007-4640 PROMACTA eltrombopag olamine GlaxoSmithKline LLC NDA Current 0007-4641 PROMACTA eltrombopag olamine GlaxoSmithKline LLC NDA Current 0007-4642 PROMACTA eltrombopag olamine GlaxoSmithKline LLC NDA Current 0007-4643 PROMACTA eltrombopag olamine GlaxoSmithKline LLC NDA Current 0078-0684 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0684 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0684 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0684 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0684 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0684 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0684 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0684 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0684 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0684 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0685 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0685 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0685 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0685 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0685 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0685 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0685 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0685 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0685 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0685 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0686 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0686 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0686 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0686 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0686 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0686 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0686 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0686 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0686 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0686 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0687 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0687 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0687 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0687 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0687 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0687 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0687 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0687 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0687 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0687 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current