Application 201275

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 12.5MG BASE	No	No
002	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 25MG BASE	No	No
003	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 37.5MG BASE	No	No
004	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 50MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A201275-001	SUNITINIB MALATE	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-12-06
A201275-002	SUNITINIB MALATE	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-12-06
A201275-003	SUNITINIB MALATE	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-12-06
A201275-004	SUNITINIB MALATE	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201275-001	AB
A201275-002	AB
A201275-003	AB
A201275-004	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 1 of 4 · 136 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
2026-08-18 06:07:40	2026-07	A201275-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201275-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201275-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201275-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201275-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201275-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201275-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201275-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201275-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201275-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201275-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201275-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201275-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201275-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201275-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201275-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201275-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201275-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201275-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201275-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201275-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201275-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201275-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201275-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-12-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201275-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201275-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201275-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201275-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-12-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201275-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201275-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-12-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201275-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201275-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-12-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201275-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201275-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-12-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201275-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201275-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-12-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201275-001	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201275-002	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE / ORAL	AB	2021-12-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201275-003	SUNITINIB MALATE	EQ 37.5MG BASE	CAPSULE / ORAL	AB	2021-12-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201275-004	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE / ORAL	AB	2021-12-06	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201275-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201275-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201275-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201275-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201275-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201275-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201275-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201275-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201275-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201275-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201275-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201275-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201275-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201275-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201275-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201275-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201275-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201275-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201275-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201275-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201275-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201275-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201275-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201275-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201275-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201275-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201275-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201275-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201275-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201275-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201275-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201275-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201275-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201275-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201275-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201275-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201275-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201275-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201275-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201275-004	AB	1	`d8e5a09893c0…`

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
Sunitinib Malate	SUNITINIB MALATE	Mylan Pharmaceuticals Inc.	4dbfcc02-dacc-4f0c-9f41-095783b68e27	2023-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201275 application number: ANDA201275 ndc (product): 0378-6679 ndc (product): 0378-6680 ndc (product): 0378-6681 ndc (product): 0378-6678

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6678	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6678	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6679	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6679	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6680	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6680	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6681	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6681	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40054	ORIG	2014-02-14
9869	ORIG	2014-02-04