Application 207777

Type: ANDA
Sponsor: GLENMARK PHARMS SA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	APREPITANT	APREPITANT	CAPSULE;ORAL	40MG	No	No
002	APREPITANT	APREPITANT	CAPSULE;ORAL	80MG	No	No
003	APREPITANT	APREPITANT	CAPSULE;ORAL	125MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A207777-001	APREPITANT	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12
A207777-002	APREPITANT	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12
A207777-003	APREPITANT	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A207777-001	AB
A207777-002	AB
A207777-003	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 · 126 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	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207777-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207777-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207777-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207777-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207777-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207777-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207777-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207777-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207777-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207777-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207777-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207777-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207777-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207777-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207777-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207777-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207777-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207777-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207777-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207777-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207777-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207777-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207777-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207777-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207777-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2017-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207777-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2017-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207777-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2017-10-12	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A207777-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207777-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207777-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207777-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207777-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207777-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207777-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207777-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207777-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207777-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207777-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207777-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207777-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207777-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207777-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207777-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207777-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207777-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207777-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207777-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207777-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207777-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207777-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207777-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207777-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207777-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207777-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207777-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207777-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207777-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207777-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207777-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207777-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207777-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207777-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207777-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207777-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207777-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207777-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207777-001	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
Aprepitant	APREPITANT	BluePoint Laboratories	a78aaa00-a46b-4f9e-a415-2fca9e9a4fb4	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207777 application number: ANDA207777
Aprepitant	APREPITANT	Glenmark Pharmaceuticals Inc., USA	d72e0e10-4557-41b0-b65d-d395468cad19	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207777 application number: ANDA207777 ndc (product): 68462-584 ndc (product): 68462-583 ndc (product): 68462-585 ndc (product): 68462-112

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68462-112	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-112	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-112	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-112	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-583	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-583	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-583	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-583	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-584	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-584	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-584	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-584	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-585	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-585	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-585	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-585	Aprepitant	Aprepitant	Glenmark Pharmaceuticals Inc., USA	ANDA	Current