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 1.

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.

Application-product, TE code table
Application-product	TE code
N207027-001	AB
N207027-002	AB

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 · 82 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	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…`
2021-12-28 21:50 UTC	2021-12	N207027-001	PROMACTA KIT	EQ 25MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD, RS	2015-08-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207027-002	PROMACTA KIT	EQ 12.5MG ACID/PACKET	FOR SUSPENSION / ORAL		RLD	2018-09-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207027-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207027-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207027-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207027-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207027-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207027-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207027-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207027-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207027-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207027-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207027-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207027-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207027-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207027-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207027-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207027-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207027-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207027-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207027-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207027-002	AB	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N207027-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N207027-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 22 · 876 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	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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-001	7547719	2025-07-13	U-1575	Drug substance, Drug product	2015-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-001	7547719	2025-07-13	U-1736	Drug substance, Drug product	2015-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-001	7547719	2025-07-13	U-2452	Drug substance, Drug product	2015-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-001	7547719	2025-07-13	U-1306	Drug substance, Drug product	2015-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-001	7547719*PED	2026-01-13		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-002	7547719	2025-07-13	U-2452	Drug substance, Drug product	2019-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-002	7547719	2025-07-13	U-1736	Drug substance, Drug product	2019-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-002	7547719	2025-07-13	U-1575	Drug substance, Drug product	2019-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-002	7547719	2025-07-13	U-1306	Drug substance, Drug product	2019-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-002	7547719*PED	2026-01-13		Pediatric extension		`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 100 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	N207027-001	ODE*	2025-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207027-002	ODE*	2025-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207027-001	ODE*	2025-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207027-002	ODE*	2025-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-001	ODE*	2025-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207027-002	ODE*	2025-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207027-001	ODE*	2025-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207027-002	ODE*	2025-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207027-001	ODE*	2025-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207027-002	ODE*	2025-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-001	ODE*	2025-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207027-002	ODE*	2025-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-001	ODE*	2025-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207027-002	ODE*	2025-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-001	ODE*	2025-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207027-002	ODE*	2025-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207027-001	ODE*	2025-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207027-002	ODE*	2025-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207027-001	ODE*	2025-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207027-002	ODE*	2025-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207027-001	ODE*	2025-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207027-002	ODE*	2025-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207027-001	ODE*	2025-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207027-002	ODE*	2025-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207027-001	ODE*	2025-11-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207027-002	ODE*	2025-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207027-001	PED	2022-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207027-001	ODE*	2025-11-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207027-002	PED	2022-02-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207027-002	ODE*	2025-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207027-001	PED	2022-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207027-001	ODE*	2025-11-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207027-002	PED	2022-02-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207027-002	ODE*	2025-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207027-001	PED	2022-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207027-001	ODE*	2025-11-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207027-002	PED	2022-02-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207027-002	ODE*	2025-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207027-001	ODE-74	2021-08-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207027-001	PED	2022-02-26	`74a2ff9319b5…`

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82506	SUPPL	2025-06-09
82496	SUPPL	2025-06-09
82495	SUPPL	2025-06-09
73733	SUPPL	2023-03-10
73721	SUPPL	2023-03-10
70693	SUPPL	2022-04-05
70692	SUPPL	2022-04-05
70683	SUPPL	2022-04-04
66093	SUPPL	2021-02-04
66090	SUPPL	2021-02-04
66089	SUPPL	2021-02-04
66087	SUPPL	2021-02-04
66073	SUPPL	2021-02-03
62798	SUPPL	2020-05-01
62797	SUPPL	2020-05-01
62768	SUPPL	2020-04-30
58422	SUPPL	2019-04-25
58421	SUPPL	2019-04-25
55814	SUPPL	2018-10-04
55752	SUPPL	2018-10-01
55000	SUPPL	2018-07-26
54969	SUPPL	2018-07-25
54388	SUPPL	2018-05-31
54372	SUPPL	2018-05-30
48931	SUPPL	2017-07-10
47549	SUPPL	2017-03-14
47522	SUPPL	2017-03-10
45616	SUPPL	2016-10-17
45555	SUPPL	2016-10-14
43531	ORIG	2016-06-03
24523	ORIG	2016-06-03
40578	ORIG	2015-08-25
32840	ORIG	2015-08-25
51702	ORIG	2011-11-23
51700	ORIG	2010-01-25
68839	ORIG	1900-01-01
67193	SUPPL	1900-01-01
62979	SUPPL	1900-01-01