Application 218854

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	240MG	No	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
A218854-001	PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		RS	2025-12-29

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
2026-02-19 14:30 UTC	2026-02	A218854-001	PSEUDOEPHEDRINE HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		RS	2025-12-29	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218854-001	PSEUDOEPHEDRINE HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE / ORAL		RS	2025-12-29	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	WALGREEN CO.	1425a847-bf34-1795-e063-6294a90a85b6	2026-02-03	Warnings	Exact identifier application applno (ANDA): 218854 application number: ANDA218854
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Aurohealth LLC	77e4132e-470e-4fb4-bc2f-df2e59061ba9	2026-01-06	Warnings	Exact identifier application applno (ANDA): 218854 application number: ANDA218854

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84750	ORIG	2026-01-13