Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076478
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/5ML;15MG/5ML SUSPENSION;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
11/05/2003 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/30/2012 SUPPL-30 Labeling-Container/Carton Labels

Label is not available on this site.

03/30/2012 SUPPL-23 Labeling

Label is not available on this site.

03/22/2006 SUPPL-15 Labeling

Label is not available on this site.

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.

SUSPENSION;ORAL; 100MG/5ML;15MG/5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S ADVIL COLD IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/5ML;15MG/5ML SUSPENSION;ORAL Over-the-counter No 021373 PFIZER
CHILDREN'S MOTRIN COLD IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/5ML;15MG/5ML SUSPENSION;ORAL Over-the-counter Yes 021128 J AND J CONSUMER INC
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE 100MG/5ML;15MG/5ML SUSPENSION;ORAL Over-the-counter No 076478 PERRIGO

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