Application 218725

Type: ANDA
Sponsor: AUROBINDO PHARMA LIMITED

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	SOLRIAMFETOL	SOLRIAMFETOL	TABLET	75MG	No	No
003	SOLRIAMFETOL	SOLRIAMFETOL	TABLET	150MG	No	No

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

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
A218725-001	SOLRIAMFETOL HYDROCHLORIDE	SOLRIAMFETOL HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2026-10-06
A218725-002	SOLRIAMFETOL HYDROCHLORIDE	SOLRIAMFETOL HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB		2026-10-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A218725-001	AB
A218725-002	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A218725-001	SOLRIAMFETOL HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB		2026-10-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218725-002	SOLRIAMFETOL HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB		2026-10-06	`c2088c7a36db…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A218725-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A218725-002	AB	1	`c2088c7a36db…`

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
SUNOSI	SOLRIAMFETOL	Axsome Therapeutics, Inc.	362f206b-73e7-4009-8c34-5a9df55679ab	2026-05-05	Warnings, Adverse reactions	Name fallback generic name: SOLRIAMFETOL

Reported adverse events (FAERS/openFDA)#

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