Application 205426

Type: ANDA
Sponsor: BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	2.5MG	No	No
002	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	5MG	No	No
003	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	7.5MG	No	No
004	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A205426-001	EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05
A205426-002	EVEROLIMUS	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05
A205426-003	EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05
A205426-004	EVEROLIMUS	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205426-001	AB
A205426-002	AB
A205426-003	AB
A205426-004	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
2026-02-19 14:30 UTC	2026-02	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205426-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2021-03-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205426-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2021-03-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205426-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2021-03-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205426-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-03-05	`d06236e962d9…`

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
2026-02-19 14:30 UTC	2026-02	A205426-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205426-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205426-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205426-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205426-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205426-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205426-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205426-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205426-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205426-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205426-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205426-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205426-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205426-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205426-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205426-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205426-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205426-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205426-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205426-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205426-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205426-004	AB	1	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Yulithira	EVEROLIMUS	CivicaScript, LLC	5e325efa-8ae6-4dac-b59b-d7c74c73186c	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205426 application number: ANDA205426
Everolimus	EVEROLIMUS	Breckenridge Pharmaceutical, Inc.	01f7b5fb-be0d-4adf-acd2-6899018de966	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205426 application number: ANDA205426 ndc (product): 51991-821 ndc (product): 51991-823 ndc (product): 51991-824 ndc (product): 51991-822
Everolimus	EVEROLIMUS	Natco Pharma Limited	e3dbbc24-7e55-4069-a305-e2cded2db641	2023-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205426 application number: ANDA205426 ndc (product): 63850-0061 ndc (product): 63850-0059 ndc (product): 63850-0060 ndc (product): 63850-0058

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51991-821	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-821	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-821	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-821	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-822	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-822	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-822	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-822	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-823	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-823	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-823	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-823	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-824	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-824	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-824	Everolimus	Everolimus	Breckenridge Pharmaceutical, Inc.	ANDA	Current
63850-0058	Everolimus	Everolimus	Natco Pharma Limited	ANDA	Current
63850-0058	Everolimus	Everolimus	Natco Pharma Limited	ANDA	Current
63850-0059	Everolimus	Everolimus	Natco Pharma Limited	ANDA	Current
63850-0059	Everolimus	Everolimus	Natco Pharma Limited	ANDA	Current
63850-0060	Everolimus	Everolimus	Natco Pharma Limited	ANDA	Current
63850-0060	Everolimus	Everolimus	Natco Pharma Limited	ANDA	Current
63850-0061	Everolimus	Everolimus	Natco Pharma Limited	ANDA	Current
63850-0061	Everolimus	Everolimus	Natco Pharma Limited	ANDA	Current