Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213565
Company: AUROBINDO PHARMA LTD

Products on ANDA 213565

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213565

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/10/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

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

IBUPROFEN AND 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;ORAL; 200MG;30MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ADVIL COLD AND SINUS	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET;ORAL	Over-the-counter	Yes	019771	HALEON US HOLDINGS
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET;ORAL	Over-the-counter	No	213565	AUROBINDO PHARMA LTD
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET;ORAL	Over-the-counter	No	077628	STRIDES PHARMA
IBUPROHM COLD AND SINUS	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET;ORAL	Over-the-counter	No	074567	OHM LABS
SINE-AID IB	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET;ORAL	Over-the-counter	No	019899	KENVUE BRANDS