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 42 .
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PROMACTA ELTROMBOPAG OLAMINE EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16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 · 26 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 N022291-002 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 N022291-003 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 N022291-004 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 N022291-005 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 · 210 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 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 115 · 4,593 observed states.
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 N022291-001 7547719 2025-07-13 U-2451 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-001 7547719 2025-07-13 U-2452 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-001 7547719 2025-07-13 U-1575 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-001 7547719 2025-07-13 U-1306 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-001 7547719*PED 2026-01-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-002 7547719 2025-07-13 U-1575 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-002 7547719 2025-07-13 U-2452 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-002 7547719 2025-07-13 U-1306 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-002 7547719 2025-07-13 U-930 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-002 7547719 2025-07-13 U-2451 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-002 7547719*PED 2026-01-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-003 7547719 2025-07-13 U-2451 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-003 7547719 2025-07-13 U-1575 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-003 7547719 2025-07-13 U-930 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-003 7547719 2025-07-13 U-1306 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-003 7547719 2025-07-13 U-2452 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-003 7547719*PED 2026-01-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-004 7547719 2025-07-13 U-2451 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-004 7547719 2025-07-13 U-1575 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-004 7547719 2025-07-13 U-2452 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-004 7547719 2025-07-13 U-1306 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-004 7547719*PED 2026-01-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-005 7547719 2025-07-13 U-1575 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-005 7547719 2025-07-13 U-930 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-005 7547719 2025-07-13 U-1306 Drug substance, Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022291-005 7547719*PED 2026-01-13 Pediatric extension caaa826d4ba7…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…
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.
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