Application 211782

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	APREMILAST	APREMILAST	TABLET;ORAL	10MG	No	No
002	APREMILAST	APREMILAST	TABLET;ORAL	20MG	No	No
003	APREMILAST	APREMILAST	TABLET;ORAL	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A211782-001	APREMILAST	APREMILAST	10MG	TABLET / ORAL	2021-06-30
A211782-002	APREMILAST	APREMILAST	20MG	TABLET / ORAL	2021-06-30
A211782-003	APREMILAST	APREMILAST	30MG	TABLET / ORAL	2021-06-30

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 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211782-002	APREMILAST	20MG	TABLET / ORAL	2021-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211782-003	APREMILAST	30MG	TABLET / ORAL	2021-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211782-001	APREMILAST	10MG	TABLET / ORAL	2021-06-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A211782-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211782-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211782-003	AB	1	`782e0a99824c…`

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
Otezla	APREMILAST	Amgen, Inc	f6b1f516-4972-4d82-bced-113e47b41cc5	2025-12-23	Warnings, Adverse reactions	Name fallback generic name: APREMILAST

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60219-1410	APREMILAST	APREMILAST	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1744	APREMILAST	APREMILAST	Amneal Pharmaceuticals NY LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59610	ORIG	2019-08-07