Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209008
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;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
06/09/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

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, EXTENDED RELEASE;ORAL; 120MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 209008 AUROBINDO PHARMA LTD
PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 075153 L PERRIGO CO
PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 077442 SUN PHARM INDS LTD
SUDAFED 12 HOUR PSEUDOEPHEDRINE HYDROCHLORIDE 120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 073585 MCNEIL CONS

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