Application 215902

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SAFINAMIDE MESYLATE	SAFINAMIDE MESYLATE	TABLET;ORAL	EQ 50MG BASE	No	No
002	SAFINAMIDE MESYLATE	SAFINAMIDE MESYLATE	TABLET;ORAL	EQ 100MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215902-001	SAFINAMIDE MESYLATE	SAFINAMIDE MESYLATE	EQ 50MG BASE	TABLET / ORAL			2023-06-14
A215902-002	SAFINAMIDE MESYLATE	SAFINAMIDE MESYLATE	EQ 100MG BASE	TABLET / ORAL			2023-06-14

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 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215902-001	SAFINAMIDE MESYLATE	EQ 50MG BASE	TABLET / ORAL	2023-06-14	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215902-002	SAFINAMIDE MESYLATE	EQ 100MG BASE	TABLET / ORAL	2023-06-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215902-001	SAFINAMIDE MESYLATE	EQ 50MG BASE	TABLET / ORAL	2023-06-14	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215902-002	SAFINAMIDE MESYLATE	EQ 100MG BASE	TABLET / ORAL	2023-06-14	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215902-001	SAFINAMIDE MESYLATE	EQ 50MG BASE	TABLET / ORAL	2023-06-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215902-002	SAFINAMIDE MESYLATE	EQ 100MG BASE	TABLET / ORAL	2023-06-14	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74741	ORIG	2023-07-13