Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203200
Company: PERRIGO R AND D

Products on ANDA 203200

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	200MG;10MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203200

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/03/2014	ORIG-1	Approval				Label is not available on this site.

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

IBUPROFEN AND PHENYLEPHRINE 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;10MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
ADVIL CONGESTION RELIEF	IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	200MG;10MG	TABLET;ORAL	Over-the-counter	Yes	022565	HALEON US HOLDINGS
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	200MG;10MG	TABLET;ORAL	Over-the-counter	No	203200	PERRIGO R AND D