Application 202103

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DASATINIB	DASATINIB	TABLET;ORAL	20MG	No	No
002	DASATINIB	DASATINIB	TABLET;ORAL	50MG	No	No
003	DASATINIB	DASATINIB	TABLET;ORAL	70MG	No	No
004	DASATINIB	DASATINIB	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202103-001	DASATINIB	DASATINIB	20MG	TABLET / ORAL	AB	2016-06-10
A202103-002	DASATINIB	DASATINIB	50MG	TABLET / ORAL	AB	2016-06-10
A202103-003	DASATINIB	DASATINIB	70MG	TABLET / ORAL	AB	2016-06-10
A202103-004	DASATINIB	DASATINIB	100MG	TABLET / ORAL	AB	2016-06-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A202103-001	AB
A202103-002	AB
A202103-003	AB
A202103-004	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 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A202103-001	DASATINIB	20MG	TABLET / ORAL	2016-06-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202103-002	DASATINIB	50MG	TABLET / ORAL	2016-06-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202103-003	DASATINIB	70MG	TABLET / ORAL	2016-06-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202103-004	DASATINIB	100MG	TABLET / ORAL	2016-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202103-001	DASATINIB	20MG	TABLET / ORAL	2016-06-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202103-002	DASATINIB	50MG	TABLET / ORAL	2016-06-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202103-003	DASATINIB	70MG	TABLET / ORAL	2016-06-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202103-004	DASATINIB	100MG	TABLET / ORAL	2016-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202103-001	DASATINIB	20MG	TABLET / ORAL	2016-06-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202103-002	DASATINIB	50MG	TABLET / ORAL	2016-06-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202103-003	DASATINIB	70MG	TABLET / ORAL	2016-06-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202103-004	DASATINIB	100MG	TABLET / ORAL	2016-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202103-001	DASATINIB	20MG	TABLET / ORAL	2016-06-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202103-002	DASATINIB	50MG	TABLET / ORAL	2016-06-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202103-003	DASATINIB	70MG	TABLET / ORAL	2016-06-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202103-004	DASATINIB	100MG	TABLET / ORAL	2016-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202103-001	DASATINIB	20MG	TABLET / ORAL	2016-06-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202103-002	DASATINIB	50MG	TABLET / ORAL	2016-06-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202103-003	DASATINIB	70MG	TABLET / ORAL	2016-06-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202103-004	DASATINIB	100MG	TABLET / ORAL	2016-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202103-001	DASATINIB	20MG	TABLET / ORAL	2016-06-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202103-002	DASATINIB	50MG	TABLET / ORAL	2016-06-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202103-003	DASATINIB	70MG	TABLET / ORAL	2016-06-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202103-004	DASATINIB	100MG	TABLET / ORAL	2016-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202103-001	DASATINIB	20MG	TABLET / ORAL	2016-06-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202103-002	DASATINIB	50MG	TABLET / ORAL	2016-06-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202103-003	DASATINIB	70MG	TABLET / ORAL	2016-06-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202103-004	DASATINIB	100MG	TABLET / ORAL	2016-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202103-001	DASATINIB	20MG	TABLET / ORAL	2016-06-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202103-002	DASATINIB	50MG	TABLET / ORAL	2016-06-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202103-003	DASATINIB	70MG	TABLET / ORAL	2016-06-10	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202103-004	DASATINIB	100MG	TABLET / ORAL	2016-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202103-001	DASATINIB	20MG	TABLET / ORAL	2016-06-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202103-002	DASATINIB	50MG	TABLET / ORAL	2016-06-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202103-003	DASATINIB	70MG	TABLET / ORAL	2016-06-10	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202103-004	DASATINIB	100MG	TABLET / ORAL	2016-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202103-001	DASATINIB	20MG	TABLET / ORAL	2016-06-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202103-002	DASATINIB	50MG	TABLET / ORAL	2016-06-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202103-003	DASATINIB	70MG	TABLET / ORAL	2016-06-10	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202103-004	DASATINIB	100MG	TABLET / ORAL	2016-06-10	`ea99ee380514…`

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
2026-10-15 13:18:30	2026-09	A202103-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202103-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202103-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202103-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202103-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202103-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202103-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202103-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202103-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202103-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202103-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202103-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202103-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202103-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202103-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202103-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202103-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202103-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202103-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202103-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202103-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202103-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202103-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202103-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202103-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202103-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202103-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202103-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202103-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202103-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202103-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202103-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202103-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202103-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202103-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202103-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202103-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202103-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202103-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202103-004	AB	1	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202103-001	PC	2025-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202103-002	PC	2025-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202103-003	PC	2025-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202103-004	PC	2025-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202103-001	PC	2025-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202103-002	PC	2025-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202103-003	PC	2025-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202103-004	PC	2025-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202103-001	PC	2025-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202103-002	PC	2025-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202103-003	PC	2025-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202103-004	PC	2025-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202103-001	PC	2025-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202103-002	PC	2025-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202103-003	PC	2025-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202103-004	PC	2025-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202103-001	PC	2025-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202103-002	PC	2025-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202103-003	PC	2025-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202103-004	PC	2025-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202103-001	PC	2025-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202103-002	PC	2025-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202103-003	PC	2025-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202103-004	PC	2025-03-02	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202103-001	PC	2025-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202103-002	PC	2025-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202103-003	PC	2025-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202103-004	PC	2025-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202103-001	PC	2025-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202103-002	PC	2025-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202103-003	PC	2025-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202103-004	PC	2025-03-02	`d06236e962d9…`

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
Dasatinib	DASATINIB	Apotex Corp.	2ed87763-f018-abdb-c0ab-daa5e441b397	2024-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202103 application number: ANDA202103

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62200	ORIG	2020-03-19
32180	ORIG	2016-06-14