Application 208302

Type: ANDA
Sponsor: SHILPA MEDICARE LTD

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
A208302-001	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB		2019-01-17
A208302-002	IMATINIB MESYLATE	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB		2019-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208302-001	AB
A208302-002	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	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208302-001	IMATINIB MESYLATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-01-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208302-002	IMATINIB MESYLATE	EQ 400MG BASE	TABLET / ORAL	AB	2019-01-17	`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	A208302-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208302-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208302-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208302-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208302-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208302-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208302-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208302-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208302-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208302-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208302-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208302-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208302-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208302-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208302-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208302-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208302-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208302-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208302-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208302-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208302-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208302-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208302-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208302-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208302-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208302-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208302-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208302-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208302-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208302-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208302-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208302-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208302-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208302-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208302-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208302-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208302-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208302-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208302-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208302-002	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 400 mg	IMATINIB MESYLATE	Armas Pharmaceuticals Inc.	7b7cc194-29e4-4484-a364-a1ac7d7d6cf5	2019-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208302 application number: ANDA208302 ndc (product): 72485-203
Imatinib mesylate	IMATINIB MESYLATE	Armas Pharmaceuticals Inc.	2e931c49-6c9f-41e2-a34b-5f01cd295b56	2019-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208302 application number: ANDA208302 ndc (product): 72485-202
Imatinib mesylate	IMATINIB MESYLATE	Ascend Laboratories, LLC	7579620e-3748-46fa-8295-f9b47d0aa5b8	2019-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208302 application number: ANDA208302 ndc (product): 67877-633 ndc (product): 67877-634

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59923-723	Imatinib Mesylate	Imatinib Mesylate	Areva Pharmaceuticals	ANDA	Current
59923-723	Imatinib Mesylate	Imatinib Mesylate	Areva Pharmaceuticals	ANDA	Current
59923-724	Imatinib Mesylate	Imatinib Mesylate	Areva Pharmaceuticals	ANDA	Current
59923-724	Imatinib Mesylate	Imatinib Mesylate	Areva Pharmaceuticals	ANDA	Current
67877-633	Imatinib mesylate	imatinib mesylate	Ascend Laboratories, LLC	ANDA	Current
67877-634	Imatinib mesylate	imatinib mesylate	Ascend Laboratories, LLC	ANDA	Current
72485-202	Imatinib mesylate	imatinib mesylate	Armas Pharmaceuticals Inc.	ANDA	Current
72485-203	Imatinib mesylate	imatinib mesylate	Armas Pharmaceuticals Inc.	ANDA	Current
72606-556	Imatinib mesylate	imatinib mesylate	CELLTRION USA, INC.	ANDA	Current
72606-557	Imatinib mesylate	imatinib mesylate	CELLTRION USA, INC.	ANDA	Current