Application 214056

Type: NDA
Sponsor: MDD US

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ONAPGO	APOMORPHINE HYDROCHLORIDE	SOLUTION;SUBCUTANEOUS	98MG/20ML (4.9MG/ML)	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214056-001	ONAPGO	APOMORPHINE HYDROCHLORIDE	98MG/20ML (4.9MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2025-02-03

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214056-001	NP	2028-02-03

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214056-001	ONAPGO	98MG/20ML (4.9MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214056-001	ONAPGO	98MG/20ML (4.9MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214056-001	ONAPGO	98MG/20ML (4.9MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214056-001	ONAPGO	98MG/20ML (4.9MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-02-03	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214056-001	ONAPGO	98MG/20ML (4.9MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-02-03	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214056-001	NP	2028-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214056-001	NP	2028-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214056-001	NP	2028-02-03	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214056-001	NP	2028-02-03	`a50c72e98297…`

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
ONAPGO	APOMORPHINE HYDROCHLORIDE	MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc	f3552b6e-5ae7-4993-aa1a-e399c4a7080a	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214056 application number: NDA214056

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85970	SUPPL	2026-05-19
85962	SUPPL	2026-05-19
81157	ORIG	2025-02-07
81068	ORIG	2025-02-06