Application 212135

Type: ANDA
Sponsor: QILU

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
A212135-001	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB		2022-06-21
A212135-002	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB		2022-06-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212135-001	AB
A212135-002	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 2 · 56 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	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212135-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-21	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212135-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-21	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 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	A212135-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212135-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212135-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212135-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212135-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212135-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212135-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212135-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212135-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212135-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212135-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212135-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212135-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212135-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212135-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212135-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212135-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212135-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212135-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212135-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212135-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212135-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212135-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212135-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212135-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212135-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212135-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212135-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212135-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212135-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212135-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212135-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212135-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212135-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212135-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212135-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212135-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212135-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212135-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212135-002	AB	1	`a67488948f0b…`

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	Upsher-Smith Laboratories, LLC	5d07ac08-962e-41a8-8a3c-50febc8c5f34	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212135 application number: ANDA212135
imatinib mesylate	IMATINIB MESYLATE	Qilu Pharmaceutical Co., Ltd.	82eb01e0-8685-4f06-8a72-7663e8ded38f	2024-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212135 application number: ANDA212135 ndc (product): 67184-0533 ndc (product): 67184-0532
imatinib mesylate	IMATINIB MESYLATE	Archis Pharma LLC	9de8d8b9-cf88-4960-82b7-89e5ceb7720e	2023-09-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212135 application number: ANDA212135 ndc (product): 72819-186 ndc (product): 72819-185

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67184-0532	imatinib mesylate	imatinib mesylate	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0532	imatinib mesylate	imatinib mesylate	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0533	imatinib mesylate	imatinib mesylate	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
67184-0533	imatinib mesylate	imatinib mesylate	Qilu Pharmaceutical Co., Ltd.	ANDA	Current
72819-185	imatinib mesylate	imatinib mesylate	Archis Pharma LLC	ANDA	Current
72819-186	imatinib mesylate	imatinib mesylate	Archis Pharma LLC	ANDA	Current