Application 005691

Type: NDA
Sponsor: MEDPOINTE PHARM HLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	VERTAVIS	VERATRUM VIRIDE ROOT	TABLET;ORAL	130CSR UNIT	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
N005691-002	VERTAVIS	VERATRUM VIRIDE ROOT	130CSR UNIT	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	N005691-002	VERTAVIS	130CSR UNIT	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N005691-002	VERTAVIS	130CSR UNIT	TABLET / ORAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N005691-002	VERTAVIS	130CSR UNIT	TABLET / ORAL	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N005691-002	VERTAVIS	130CSR UNIT	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	Join
VERATRUM VIRIDE	VERATRUM VIRIDE ROOT	Boiron	85dcbbdb-8558-186a-e053-2a91aa0a09d2	2025-08-11	Name fallback generic name: VERATRUM VIRIDE ROOT
Veratrum viride	VERATRUM VIRIDE ROOT	Boiron	813f86d6-12cc-6300-e053-2a91aa0af346	2025-08-11	Name fallback generic name: VERATRUM VIRIDE ROOT
VERATRUM VIRIDE	VERATRUM VIRIDE ROOT	Boiron	3b8da0c4-37f1-91ea-e063-6394a90a82a3	2025-08-04	Name fallback generic name: VERATRUM VIRIDE ROOT

Reported adverse events (FAERS/openFDA)#

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