Home DailyMed a69cbb9f-d349-4cb3-a6a4-3fc649b66fe6 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:24:43 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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PROMACTA ELTROMBOPAG OLAMINE EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2012-11-16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 · 215 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 N022291-001 PROMACTA EQ 25MG ACID TABLET / ORAL AB RLD 2008-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-002 PROMACTA EQ 50MG ACID TABLET / ORAL AB RLD 2008-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-003 PROMACTA EQ 75MG ACID TABLET / ORAL AB RLD, RS 2009-09-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-004 PROMACTA EQ 12.5MG ACID TABLET / ORAL AB RLD 2011-10-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 116 · 4,619 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022291-001 7547719 2025-07-13 U-2451 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-001 7547719 2025-07-13 U-2452 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-001 7547719 2025-07-13 U-1575 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-001 7547719 2025-07-13 U-1306 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-001 7547719*PED 2026-01-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-002 7547719 2025-07-13 U-1575 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-002 7547719 2025-07-13 U-2452 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-002 7547719 2025-07-13 U-1306 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-002 7547719 2025-07-13 U-930 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-002 7547719 2025-07-13 U-2451 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-002 7547719*PED 2026-01-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-003 7547719 2025-07-13 U-2451 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-003 7547719 2025-07-13 U-1575 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-003 7547719 2025-07-13 U-930 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-003 7547719 2025-07-13 U-1306 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-003 7547719 2025-07-13 U-2452 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-003 7547719*PED 2026-01-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-004 7547719 2025-07-13 U-2451 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-004 7547719 2025-07-13 U-1575 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-004 7547719 2025-07-13 U-2452 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-004 7547719 2025-07-13 U-1306 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-004 7547719*PED 2026-01-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-005 7547719 2025-07-13 U-1575 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-005 7547719 2025-07-13 U-930 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-005 7547719 2025-07-13 U-1306 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022291-005 7547719*PED 2026-01-13 Pediatric extension 84e616aacf4f…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…
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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.