Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209008
Company: AUROBINDO PHARMA

Products on ANDA 209008

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209008

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/09/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

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; 120MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	209008	AUROBINDO PHARMA
PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	075153	L PERRIGO CO
PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE;ORAL	Over-the-counter	No	077442	SUN PHARM INDS LTD