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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077631
Company: SUN PHARM INDS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Discontinued None No No
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE;ORAL Discontinued None No No
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE;ORAL Discontinued None No No
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Discontinued 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
01/11/2008 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077631s000lbl_CKD.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077631ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/11/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077631s000lbl_CKD.pdf
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