Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210719
Company: PERRIGO R AND D
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;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
11/16/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

CETIRIZINE HYDROCHLORIDE 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.

TABLET, EXTENDED RELEASE;ORAL; 5MG;120MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 077170 IVAX SUB TEVA PHARMS
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 210719 PERRIGO R AND D
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 077991 PLD ACQUISITIONS
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter No 090922 SUN PHARM INDS LTD
ZYRTEC-D 12 HOUR CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 5MG;120MG TABLET, EXTENDED RELEASE;ORAL Over-the-counter Yes 021150 J AND J CONSUMER INC

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