Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 218854
Company: AUROBINDO PHARMA LTD

Products on ANDA 218854

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218854

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218854Orig1s000ltr.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

PSEUDOEPHEDRINE HYDROCHLORIDE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, EXTENDED RELEASE;ORAL; 240MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	240MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	218854	AUROBINDO PHARMA LTD