Application 207486

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

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
A207486-001	EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08
A207486-002	EVEROLIMUS	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08
A207486-003	EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08
A207486-004	EVEROLIMUS	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207486-001	AB
A207486-002	AB
A207486-003	AB
A207486-004	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 · 144 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	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207486-001	EVEROLIMUS	2.5MG	TABLET / ORAL	AB	2020-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207486-002	EVEROLIMUS	5MG	TABLET / ORAL	AB	2020-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207486-003	EVEROLIMUS	7.5MG	TABLET / ORAL	AB	2020-06-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207486-004	EVEROLIMUS	10MG	TABLET / ORAL	AB	2021-11-23	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 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	A207486-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207486-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207486-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207486-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207486-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207486-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207486-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207486-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207486-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207486-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207486-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207486-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207486-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207486-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207486-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207486-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207486-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207486-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207486-004	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Everolimus	EVEROLIMUS	Hikma Pharmaceuticals USA Inc.	5aaf2fb7-93f6-40d6-941a-9583a3794ce7	2024-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207486 application number: ANDA207486 ndc (product): 0054-0480 ndc (product): 0054-0497 ndc (product): 0054-0481 ndc (product): 0054-0482

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0480	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0480	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0480	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0480	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0480	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0480	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0481	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0481	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0481	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0481	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0481	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0481	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0482	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0482	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0482	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0497	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0497	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0497	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0497	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0497	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0497	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59593	ORIG	2019-08-06