Application 205432

Type: ANDA
Sponsor: BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	0.25MG	No	No
002	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	0.5MG	No	No
003	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	0.75MG	No	No
004	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	1MG	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
A205432-001	EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20
A205432-002	EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20
A205432-003	EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-05-20
A205432-004	EVEROLIMUS	EVEROLIMUS	1MG	TABLET / ORAL	AB	2025-09-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205432-001	AB
A205432-002	AB
A205432-003	AB
A205432-004	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 3 · 102 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	A205432-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205432-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205432-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205432-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2025-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205432-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205432-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205432-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205432-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	2025-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205432-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205432-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205432-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205432-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205432-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205432-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205432-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205432-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205432-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205432-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205432-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205432-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205432-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205432-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205432-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205432-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205432-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205432-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205432-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205432-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205432-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205432-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205432-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205432-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205432-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205432-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205432-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205432-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205432-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205432-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB	2021-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205432-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB	2021-05-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205432-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB	2021-05-20	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 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	A205432-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205432-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205432-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205432-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205432-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205432-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205432-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205432-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205432-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205432-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205432-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205432-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205432-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205432-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205432-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205432-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205432-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205432-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205432-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205432-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205432-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205432-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205432-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205432-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205432-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205432-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205432-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205432-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205432-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205432-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205432-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205432-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205432-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205432-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205432-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205432-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205432-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205432-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205432-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205432-002	AB	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Everolimus	EVEROLIMUS TABLETS	Breckenridge Pharmaceutical, Inc.	c7bb6ba1-9a7f-43f5-b058-ef26d4b59221	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205432 application number: ANDA205432 ndc (product): 51991-380 ndc (product): 51991-381 ndc (product): 51991-379
Everolimus	EVEROLIMUS	Natco Pharma Limited	d44998bb-5deb-4ee7-a0a5-979fe3f49557	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205432 application number: ANDA205432 ndc (product): 63850-0063 ndc (product): 63850-0062 ndc (product): 63850-0064

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
51991-379	Everolimus	Everolimus tablets	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-380	Everolimus	Everolimus tablets	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-381	Everolimus	Everolimus tablets	Breckenridge Pharmaceutical, Inc.	ANDA	Current
63850-0062	Everolimus	Everolimus	Natco Pharma Limited	ANDA	Current
63850-0063	Everolimus	Everolimus	Natco Pharma Limited	ANDA	Current
63850-0064	Everolimus	Everolimus	Natco Pharma Limited	ANDA	Current