Application 219097

Type: NDA
Sponsor: SHORLA ONCOLOGY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMKELDI	IMATINIB MESYLATE	SOLUTION;ORAL	EQ 80MG BASE/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219097-001	IMKELDI	IMATINIB MESYLATE	EQ 80MG BASE/ML	SOLUTION / ORAL		RLD, RS	2024-11-22

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219097-001	11957681	2040-04-27		Drug product	2024-11-27

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N219097-001	IMKELDI	EQ 80MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219097-001	IMKELDI	EQ 80MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219097-001	IMKELDI	EQ 80MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219097-001	IMKELDI	EQ 80MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219097-001	IMKELDI	EQ 80MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219097-001	IMKELDI	EQ 80MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219097-001	IMKELDI	EQ 80MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219097-001	IMKELDI	EQ 80MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-11-22	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219097-001	IMKELDI	EQ 80MG BASE/ML	SOLUTION / ORAL	RLD, RS	2024-11-22	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N219097-001	11957681	2040-04-27	Drug product	2024-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219097-001	11957681	2040-04-27	Drug product	2024-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219097-001	11957681	2040-04-27	Drug product	2024-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219097-001	11957681	2040-04-27	Drug product	2024-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219097-001	11957681	2040-04-27	Drug product	2024-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219097-001	11957681	2040-04-27	Drug product	2024-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219097-001	11957681	2040-04-27	Drug product	2024-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219097-001	11957681	2040-04-27	Drug product	2024-11-27	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219097-001	11957681	2040-04-27	Drug product	2024-11-27	`a50c72e98297…`

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
IMKELDI	IMATINIB ORAL	Shorla Oncology Inc.,	26658bb7-9ba1-a10e-e063-6394a90a172e	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219097 application number: NDA219097

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82126	ORIG	2025-05-01
80427	ORIG	2024-11-26
80358	ORIG	2024-11-25