Application 079179

Type: ANDA
Sponsor: APOTEX

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
A079179-001	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB		2016-08-05
A079179-002	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB		2016-08-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A079179-001	AB
A079179-002	AB

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	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079179-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-08-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079179-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2016-08-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A079179-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079179-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079179-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079179-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079179-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079179-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079179-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079179-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079179-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079179-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079179-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079179-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079179-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079179-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079179-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079179-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079179-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079179-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079179-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079179-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079179-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079179-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079179-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079179-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079179-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079179-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079179-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079179-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079179-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079179-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079179-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079179-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079179-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079179-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079179-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079179-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079179-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079179-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079179-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079179-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Imatinib Mesylate	IMATINIB MESYLATE	Apotex Corp	0291eca5-7a1d-4a79-30be-252224d96509	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079179 application number: ANDA079179 ndc (product): 60505-2900 ndc (product): 60505-2901
Imatinib Mesylate	IMATINIB MESYLATE	Major Pharmaceuticals	7c037022-7fc8-4b6e-9db3-427206c572b4	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079179 application number: ANDA079179 ndc (product): 0904-6901 ndc (product): 0904-6621
Imatinib Mesylate	IMATINIB MESYLATE	American Health Packaging	6e7ed4ef-24e3-4545-9a99-2e34c946e8e7	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079179 application number: ANDA079179

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6621	Imatinib Mesylate	Imatinib Mesylate	Major Pharmaceuticals	ANDA	Current
0904-6621	Imatinib Mesylate	Imatinib Mesylate	Major Pharmaceuticals	ANDA	Current
0904-6621	Imatinib Mesylate	Imatinib Mesylate	Major Pharmaceuticals	ANDA	Current
0904-6621	Imatinib Mesylate	Imatinib Mesylate	Major Pharmaceuticals	ANDA	Current
0904-6901	Imatinib Mesylate	Imatinib Mesylate	Major Pharmaceuticals	ANDA	Current
0904-6901	Imatinib Mesylate	Imatinib Mesylate	Major Pharmaceuticals	ANDA	Current
0904-6901	Imatinib Mesylate	Imatinib Mesylate	Major Pharmaceuticals	ANDA	Current
0904-6901	Imatinib Mesylate	Imatinib Mesylate	Major Pharmaceuticals	ANDA	Current
50268-426	Imatinib Mesylate	Imatinib Mesylate	AvPAK	ANDA	Current
50268-426	Imatinib Mesylate	Imatinib Mesylate	AvPAK	ANDA	Current
50268-427	Imatinib Mesylate	Imatinib Mesylate	AvPAK	ANDA	Current
50268-427	Imatinib Mesylate	Imatinib Mesylate	AvPAK	ANDA	Current
50268-427	Imatinib Mesylate	Imatinib Mesylate	AvPAK	ANDA	Current
60505-2900	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current
60505-2900	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current
60505-2900	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current
60505-2900	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current
60505-2900	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current
60505-2900	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current
60505-2900	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current
60505-2901	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current
60505-2901	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current
60505-2901	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current
60505-2901	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current
60505-2901	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current
60505-2901	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current
60505-2901	Imatinib Mesylate	Imatinib Mesylate	Apotex Corp	ANDA	Current