Drugs@FDA: FDA Approved Drug Products

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

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 PFIZER
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET;ORAL Over-the-counter No 203200 PERRIGO R AND D

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