Application 211835

Type: ANDA
Sponsor: TORRENT

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
A211835-001	APREPITANT	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21
A211835-002	APREPITANT	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21
A211835-003	APREPITANT	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211835-001	AB
A211835-002	AB
A211835-003	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 3 · 111 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	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211835-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211835-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211835-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211835-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211835-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211835-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211835-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211835-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211835-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211835-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211835-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211835-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211835-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211835-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211835-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211835-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211835-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211835-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211835-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211835-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211835-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211835-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211835-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211835-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211835-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2020-10-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211835-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2020-10-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211835-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2020-10-21	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A211835-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211835-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211835-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211835-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211835-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211835-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211835-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211835-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211835-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211835-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211835-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211835-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211835-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211835-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211835-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211835-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211835-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211835-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211835-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211835-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211835-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211835-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211835-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211835-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211835-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211835-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211835-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211835-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211835-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211835-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211835-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211835-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211835-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211835-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211835-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211835-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211835-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211835-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211835-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211835-001	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	Torrent Pharmaceuticals Limited	af9b6086-4bf2-472c-8740-4134eaaebace	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211835 application number: ANDA211835 ndc (product): 13668-592 ndc (product): 13668-591 ndc (product): 13668-593 ndc (product): 13668-594
APREPITANT	APREPITANT	Golden State Medical Supply, Inc.	377c3ecb-fdec-dde4-e063-6294a90a29bd	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211835 application number: ANDA211835

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13668-591	APREPITANT	APREPITANT	Torrent Pharmaceuticals Limited	ANDA	Current
13668-591	APREPITANT	APREPITANT	Torrent Pharmaceuticals Limited	ANDA	Current
13668-591	APREPITANT	APREPITANT	Torrent Pharmaceuticals Limited	ANDA	Current
13668-592	APREPITANT	APREPITANT	Torrent Pharmaceuticals Limited	ANDA	Current
13668-592	APREPITANT	APREPITANT	Torrent Pharmaceuticals Limited	ANDA	Current
13668-592	APREPITANT	APREPITANT	Torrent Pharmaceuticals Limited	ANDA	Current
13668-593	APREPITANT	APREPITANT	Torrent Pharmaceuticals Limited	ANDA	Current
13668-593	APREPITANT	APREPITANT	Torrent Pharmaceuticals Limited	ANDA	Current
13668-593	APREPITANT	APREPITANT	Torrent Pharmaceuticals Limited	ANDA	Current
13668-594	APREPITANT	APREPITANT	Torrent Pharmaceuticals Limited	ANDA	Current
13668-594	APREPITANT	APREPITANT	Torrent Pharmaceuticals Limited	ANDA	Current
13668-594	APREPITANT	APREPITANT	Torrent Pharmaceuticals Limited	ANDA	Current