Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 209235
Company: AUROBINDO PHARMA

Products on ANDA 209235

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209235

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209235s000ltr.pdf

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.

CAPSULE;ORAL; EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ADVIL COLD AND SINUS	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE;ORAL	Over-the-counter	Yes	021374	HALEON US HOLDINGS
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	EQ 200MG FREE ACID AND POTASSIUM SALT;30MG	CAPSULE;ORAL	Over-the-counter	No	209235	AUROBINDO PHARMA