Application 016769

Type: NDA
Sponsor: ORTHO MCNEIL JANSSEN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	URISPAS	FLAVOXATE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N016769-001	URISPAS	FLAVOXATE HYDROCHLORIDE	100MG	TABLET / ORAL		Approved before 1982

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N016769-001	URISPAS	100MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N016769-001	URISPAS	100MG	TABLET / ORAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N016769-001	URISPAS	100MG	TABLET / ORAL	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N016769-001	URISPAS	100MG	TABLET / ORAL	Approved before 1982	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flavoxate Hydrochloride	FLAVOXATE HYDROCHLORIDE	PuraCap Laboratories LLC dba Blu Pharmaceuticals	f6a06eda-2480-4c0d-8d1e-9e3e89d3ee88	2025-12-11	Warnings, Adverse reactions	Name fallback generic name: FLAVOXATE HYDROCHLORIDE
Flavoxate Hydrochloride	FLAVOXATE HYDROCHLORIDE	Epic Pharma, LLC	b4260d7e-2ab3-49f6-aa57-bae19a23d82a	2023-12-27	Warnings, Adverse reactions	Name fallback generic name: FLAVOXATE HYDROCHLORIDE
FLAVOXATE HYDROCHLORIDE	FLAVOXATE HYDROCHLORIDE	Padagis US LLC	a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5	2023-05-31	Warnings, Adverse reactions	Name fallback generic name: FLAVOXATE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.