Application 090999

Type: ANDA
Sponsor: SANDOZ

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
A090999-001	APREPITANT	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24
A090999-002	APREPITANT	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24
A090999-003	APREPITANT	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090999-001	AB
A090999-002	AB
A090999-003	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	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090999-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090999-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090999-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090999-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090999-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090999-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090999-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090999-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090999-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090999-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090999-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090999-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090999-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090999-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090999-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090999-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090999-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090999-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090999-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090999-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090999-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090999-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090999-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090999-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090999-002	APREPITANT	80MG	CAPSULE / ORAL	AB	2012-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090999-003	APREPITANT	125MG	CAPSULE / ORAL	AB	2012-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090999-001	APREPITANT	40MG	CAPSULE / ORAL	AB	2012-09-24	`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	A090999-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090999-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090999-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090999-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090999-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090999-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090999-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090999-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090999-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090999-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090999-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090999-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090999-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090999-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090999-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090999-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090999-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090999-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090999-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090999-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090999-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090999-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090999-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090999-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090999-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090999-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090999-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090999-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090999-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090999-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090999-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090999-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090999-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090999-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090999-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090999-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090999-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090999-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090999-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090999-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aprepitant	APREPITANT	Sandoz Inc	f58b8944-93ee-4be1-a238-cc0061ddd93a	2024-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090999 application number: ANDA090999 ndc (product): 0781-4063 ndc (product): 0781-2321 ndc (product): 0781-2323 ndc (product): 0781-2322

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-2321	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2321	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2321	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2321	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2321	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2322	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2322	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2322	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2322	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2322	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2323	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2323	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2323	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2323	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-2323	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-4063	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-4063	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-4063	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-4063	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current
0781-4063	Aprepitant	aprepitant	Sandoz Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22720	ORIG	2013-04-10