Application 214138

Type: ANDA
Sponsor: ALKEM LABS LTD

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 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	RLD / RS	Approval date
A214138-001	EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET / ORAL	AB		2021-11-26
A214138-002	EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET / ORAL	AB		2021-11-26
A214138-003	EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET / ORAL	AB		2021-11-26
A214138-004	EVEROLIMUS	EVEROLIMUS	1MG	TABLET / ORAL	AB	RS	2021-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214138-001	AB
A214138-002	AB
A214138-003	AB
A214138-004	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214138-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB		2021-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214138-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB		2021-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214138-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB		2021-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214138-004	EVEROLIMUS	1MG	TABLET / ORAL	AB	RS	2021-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214138-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB		2021-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214138-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB		2021-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214138-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB		2021-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214138-004	EVEROLIMUS	1MG	TABLET / ORAL	AB		2021-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214138-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB		2021-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214138-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB		2021-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214138-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB		2021-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214138-004	EVEROLIMUS	1MG	TABLET / ORAL	AB		2021-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214138-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB		2021-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214138-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB		2021-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214138-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB		2021-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214138-004	EVEROLIMUS	1MG	TABLET / ORAL	AB		2021-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214138-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB		2021-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214138-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB		2021-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214138-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB		2021-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214138-004	EVEROLIMUS	1MG	TABLET / ORAL	AB		2021-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214138-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB		2021-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214138-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB		2021-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214138-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB		2021-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214138-004	EVEROLIMUS	1MG	TABLET / ORAL	AB		2021-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214138-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB		2021-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214138-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB		2021-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214138-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB		2021-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214138-004	EVEROLIMUS	1MG	TABLET / ORAL	AB		2021-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214138-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB		2021-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214138-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB		2021-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214138-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB		2021-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214138-004	EVEROLIMUS	1MG	TABLET / ORAL	AB		2021-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214138-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB		2021-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214138-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB		2021-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214138-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB		2021-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214138-004	EVEROLIMUS	1MG	TABLET / ORAL	AB		2021-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214138-001	EVEROLIMUS	0.25MG	TABLET / ORAL	AB		2021-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214138-002	EVEROLIMUS	0.5MG	TABLET / ORAL	AB		2021-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214138-003	EVEROLIMUS	0.75MG	TABLET / ORAL	AB		2021-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214138-004	EVEROLIMUS	1MG	TABLET / ORAL	AB		2021-11-26	`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	A214138-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214138-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214138-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214138-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214138-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214138-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214138-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214138-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214138-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214138-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214138-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214138-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214138-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214138-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214138-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214138-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214138-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214138-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214138-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214138-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214138-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214138-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214138-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214138-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214138-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214138-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214138-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214138-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214138-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214138-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214138-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214138-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214138-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214138-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214138-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214138-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214138-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214138-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214138-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214138-004	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
Everolimus	EVEROLIMUS	Ascend Laboratories, LLC	2693c497-a70b-4d00-b6db-602c872e5bed	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214138 application number: ANDA214138 ndc (product): 67877-718 ndc (product): 67877-721 ndc (product): 67877-719 ndc (product): 67877-720

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
67877-718	Everolimus	Everolimus	Ascend Laboratories, LLC	ANDA	Current
67877-718	Everolimus	Everolimus	Ascend Laboratories, LLC	ANDA	Current
67877-719	Everolimus	Everolimus	Ascend Laboratories, LLC	ANDA	Current
67877-719	Everolimus	Everolimus	Ascend Laboratories, LLC	ANDA	Current
67877-720	Everolimus	Everolimus	Ascend Laboratories, LLC	ANDA	Current
67877-720	Everolimus	Everolimus	Ascend Laboratories, LLC	ANDA	Current
67877-721	Everolimus	Everolimus	Ascend Laboratories, LLC	ANDA	Current
67877-721	Everolimus	Everolimus	Ascend Laboratories, LLC	ANDA	Current