Home Applications 207027 Application 207027
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PROMACTA KIT ELTROMBOPAG OLAMINE FOR SUSPENSION;ORAL EQ 25MG ACID/PACKET Yes Yes 002 PROMACTA KIT ELTROMBOPAG OLAMINE FOR SUSPENSION;ORAL EQ 12.5MG ACID/PACKET Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207027-001 PROMACTA KIT ELTROMBOPAG OLAMINE EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 N207027-002 PROMACTA KIT ELTROMBOPAG OLAMINE EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207027-001 7547719 2025-07-13 U-1306 Drug substance, Drug product 2015-09-21 N207027-001 7547719 2025-07-13 U-1575 Drug substance, Drug product 2015-09-21 N207027-001 7547719 2025-07-13 U-1736 Drug substance, Drug product 2015-09-21 N207027-001 7547719 2025-07-13 U-2452 Drug substance, Drug product 2015-09-21 N207027-001 7547719*PED 2026-01-13 Pediatric extension N207027-002 7547719 2025-07-13 U-1306 Drug substance, Drug product 2019-04-05 N207027-002 7547719 2025-07-13 U-1575 Drug substance, Drug product 2019-04-05 N207027-002 7547719 2025-07-13 U-1736 Drug substance, Drug product 2019-04-05 N207027-002 7547719 2025-07-13 U-2452 Drug substance, Drug product 2019-04-05 N207027-002 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 3 · 84 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 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2015-08-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL AB RLD 2018-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL RLD, RS 2015-08-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL RLD 2018-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL RLD, RS 2015-08-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL RLD 2018-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL RLD, RS 2015-08-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL RLD 2018-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL RLD, RS 2015-08-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL RLD 2018-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207027-001 PROMACTA KIT EQ 25MG ACID/PACKET FOR SUSPENSION / ORAL RLD, RS 2015-08-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N207027-002 PROMACTA KIT EQ 12.5MG ACID/PACKET FOR SUSPENSION / ORAL RLD 2018-09-27 bb7c543d1eb4…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 23 · 886 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 N207027-001 7547719 2025-07-13 U-1575 Drug substance, Drug product 2015-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207027-001 7547719 2025-07-13 U-1736 Drug substance, Drug product 2015-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207027-001 7547719 2025-07-13 U-2452 Drug substance, Drug product 2015-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207027-001 7547719 2025-07-13 U-1306 Drug substance, Drug product 2015-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207027-001 7547719*PED 2026-01-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207027-002 7547719 2025-07-13 U-2452 Drug substance, Drug product 2019-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207027-002 7547719 2025-07-13 U-1736 Drug substance, Drug product 2019-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207027-002 7547719 2025-07-13 U-1575 Drug substance, Drug product 2019-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207027-002 7547719 2025-07-13 U-1306 Drug substance, Drug product 2019-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207027-002 7547719*PED 2026-01-13 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207027-001 7547719 2025-07-13 U-1575 Drug substance, Drug product 2015-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207027-001 7547719 2025-07-13 U-1736 Drug substance, Drug product 2015-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207027-001 7547719 2025-07-13 U-2452 Drug substance, Drug product 2015-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207027-001 7547719 2025-07-13 U-1306 Drug substance, Drug product 2015-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207027-001 7547719*PED 2026-01-13 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207027-002 7547719 2025-07-13 U-2452 Drug substance, Drug product 2019-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207027-002 7547719 2025-07-13 U-1736 Drug substance, Drug product 2019-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207027-002 7547719 2025-07-13 U-1575 Drug substance, Drug product 2019-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207027-002 7547719 2025-07-13 U-1306 Drug substance, Drug product 2019-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207027-002 7547719*PED 2026-01-13 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207027-001 7547719 2025-07-13 U-1575 Drug substance, Drug product 2015-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207027-001 7547719 2025-07-13 U-1736 Drug substance, Drug product 2015-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207027-001 7547719 2025-07-13 U-2452 Drug substance, Drug product 2015-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207027-001 7547719 2025-07-13 U-1306 Drug substance, Drug product 2015-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207027-001 7547719*PED 2026-01-13 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207027-002 7547719 2025-07-13 U-2452 Drug substance, Drug product 2019-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207027-002 7547719 2025-07-13 U-1736 Drug substance, Drug product 2019-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207027-002 7547719 2025-07-13 U-1575 Drug substance, Drug product 2019-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207027-002 7547719 2025-07-13 U-1306 Drug substance, Drug product 2019-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207027-002 7547719*PED 2026-01-13 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207027-001 7547719 2025-07-13 U-1575 Drug substance, Drug product 2015-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207027-001 7547719 2025-07-13 U-1736 Drug substance, Drug product 2015-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207027-001 7547719 2025-07-13 U-2452 Drug substance, Drug product 2015-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207027-001 7547719 2025-07-13 U-1306 Drug substance, Drug product 2015-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207027-001 7547719*PED 2026-01-13 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207027-002 7547719 2025-07-13 U-2452 Drug substance, Drug product 2019-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207027-002 7547719 2025-07-13 U-1736 Drug substance, Drug product 2019-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207027-002 7547719 2025-07-13 U-1575 Drug substance, Drug product 2019-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207027-002 7547719 2025-07-13 U-1306 Drug substance, Drug product 2019-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207027-002 7547719*PED 2026-01-13 Pediatric extension 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 100 observed states.
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): 207027 application number: NDA207027 ndc (product): 0078-0697 ndc (product): 0078-0972
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 17 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0697 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0697 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0697 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0697 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0697 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0697 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0697 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0972 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0972 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0972 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0972 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0972 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0972 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0972 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0972 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0972 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current 0078-0972 PROMACTA eltrombopag olamine Novartis Pharmaceuticals Corporation NDA Current