U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022429
Company: BIONPHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG CAPSULE;ORAL Over-the-counter None Yes No
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter None Yes Yes
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter None Yes Yes
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG CAPSULE;ORAL Over-the-counter None Yes 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
07/23/2009 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022429_cetirizine_hydrochloride_toc.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/30/2026 SUPPL-26 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022429Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/022429Orig1s026ltr.pdf
12/07/2020 SUPPL-17 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022429Orig1s017ltr.pdf
12/13/2019 SUPPL-14 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022429Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022429Orig1s014ltr.pdf
02/06/2013 SUPPL-9 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022429Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022429Orig1s009ltr.pdf
04/06/2010 SUPPL-3 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022429s003ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/30/2026 SUPPL-26 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022429Orig1s026lbl.pdf
12/13/2019 SUPPL-14 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022429Orig1s014lbl.pdf
02/06/2013 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022429Orig1s009lbl.pdf

CETIRIZINE HYDROCHLORIDE ALLERGY

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE;ORAL; 5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 209107 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 213105 CATALENT
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 205291 ONESOURCE SPECIALTY
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 209107 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE;ORAL; 5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 209107 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 213105 CATALENT
CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 205291 ONESOURCE SPECIALTY
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter No 209107 AUROBINDO PHARMA LTD
CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG CAPSULE;ORAL Over-the-counter Yes 022429 BIONPHARMA
Back to Top