Application 078340

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMATINIB MESYLATE	IMATINIB MESYLATE	TABLET;ORAL	EQ 100MG BASE	No	No
002	IMATINIB MESYLATE	IMATINIB MESYLATE	TABLET;ORAL	EQ 400MG BASE	No	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
A078340-001	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL			2015-12-03
A078340-002	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL			2015-12-03

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078340-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2015-12-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078340-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2015-12-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078340-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078340-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078340-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078340-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078340-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078340-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078340-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078340-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078340-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078340-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078340-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078340-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078340-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078340-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078340-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078340-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078340-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078340-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078340-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078340-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078340-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078340-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078340-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078340-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078340-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078340-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078340-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078340-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078340-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078340-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078340-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078340-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078340-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078340-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078340-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078340-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078340-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078340-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078340-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078340-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
imatinib mesylate	IMATINIB MESYLATE	Sun Pharmaceutical Industries, Inc.	07764bf9-21b4-4e32-9d7e-e348f8e4291f	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078340 application number: ANDA078340 ndc (product): 47335-475 ndc (product): 47335-472
imatinib mesylate	IMATINIB MESYLATE	BluePoint Laboratories	be5b9047-155b-59ca-e053-2995a90ad3dc	2023-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078340 application number: ANDA078340 ndc (product): 68001-491 ndc (product): 68001-490

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-704	imatinib mesylate	imatinib mesylate	NorthStar RxLLC	ANDA	Current
16714-704	imatinib mesylate	imatinib mesylate	NorthStar RxLLC	ANDA	Current
16714-704	imatinib mesylate	imatinib mesylate	NorthStar RxLLC	ANDA	Current
16714-704	imatinib mesylate	imatinib mesylate	NorthStar RxLLC	ANDA	Current
16714-704	imatinib mesylate	imatinib mesylate	NorthStar RxLLC	ANDA	Current
16714-704	imatinib mesylate	imatinib mesylate	NorthStar RxLLC	ANDA	Current
16714-705	imatinib mesylate	imatinib mesylate	NorthStar RxLLC	ANDA	Current
16714-705	imatinib mesylate	imatinib mesylate	NorthStar RxLLC	ANDA	Current
16714-705	imatinib mesylate	imatinib mesylate	NorthStar RxLLC	ANDA	Current
16714-705	imatinib mesylate	imatinib mesylate	NorthStar RxLLC	ANDA	Current
16714-705	imatinib mesylate	imatinib mesylate	NorthStar RxLLC	ANDA	Current
16714-705	imatinib mesylate	imatinib mesylate	NorthStar RxLLC	ANDA	Current
47335-472	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-472	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-472	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-472	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-472	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-472	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-472	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-475	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-475	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-475	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-475	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-475	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-475	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-475	imatinib mesylate	imatinib mesylate	Sun Pharmaceutical Industries, Inc.	ANDA	Current
60687-192	Imatinib Mesylate	Imatinib Mesylate	American Health Packaging	ANDA	Current
60687-192	Imatinib Mesylate	Imatinib Mesylate	American Health Packaging	ANDA	Current
60687-192	Imatinib Mesylate	Imatinib Mesylate	American Health Packaging	ANDA	Current
60687-192	Imatinib Mesylate	Imatinib Mesylate	American Health Packaging	ANDA	Current
60687-203	Imatinib Mesylate	Imatinib Mesylate	American Health Packaging	ANDA	Current
60687-203	Imatinib Mesylate	Imatinib Mesylate	American Health Packaging	ANDA	Current
60687-203	Imatinib Mesylate	Imatinib Mesylate	American Health Packaging	ANDA	Current
60687-203	Imatinib Mesylate	Imatinib Mesylate	American Health Packaging	ANDA	Current
68001-490	imatinib mesylate	imatinib mesylate	BluePoint Laboratories	ANDA	Current
68001-490	imatinib mesylate	imatinib mesylate	BluePoint Laboratories	ANDA	Current
68001-490	imatinib mesylate	imatinib mesylate	BluePoint Laboratories	ANDA	Current
68001-490	imatinib mesylate	imatinib mesylate	BluePoint Laboratories	ANDA	Current
68001-491	imatinib mesylate	imatinib mesylate	BluePoint Laboratories	ANDA	Current
68001-491	imatinib mesylate	imatinib mesylate	BluePoint Laboratories	ANDA	Current
68001-491	imatinib mesylate	imatinib mesylate	BluePoint Laboratories	ANDA	Current
68001-491	imatinib mesylate	imatinib mesylate	BluePoint Laboratories	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31357	ORIG	2015-12-08