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

Abbreviated New Drug Application (ANDA): 090474
Company: APOZEAL PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter None No No
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;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
03/30/2009 ORIG-1 Approval

Label is not available on this site.

CHILDREN'S 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.

SOLUTION;ORAL; 5MG/5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090765 AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090474 APOZEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090750 AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 091327 BAJAJ
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 091130 CHARTWELL MOLECULAR
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 210622 HETERO LABS LTD III
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090254 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 204226 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 212266 QUAGEN
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090182 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 201546 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090765 AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090474 APOZEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090750 AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 091327 BAJAJ
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 091130 CHARTWELL MOLECULAR
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090254 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090182 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 201546 TARO
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter Yes 022155 KENVUE BRANDS
CHILDREN'S ZYRTEC HIVES CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter Yes 022155 KENVUE BRANDS

CHILDREN'S 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.

SOLUTION;ORAL; 5MG/5ML
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090765 AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090474 APOZEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090750 AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 091327 BAJAJ
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 091130 CHARTWELL MOLECULAR
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 210622 HETERO LABS LTD III
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090254 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 204226 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 212266 QUAGEN
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090182 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 201546 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090765 AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090474 APOZEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090750 AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 091327 BAJAJ
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 091130 CHARTWELL MOLECULAR
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090254 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 090182 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter No 201546 TARO
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter Yes 022155 KENVUE BRANDS
CHILDREN'S ZYRTEC HIVES CETIRIZINE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Over-the-counter Yes 022155 KENVUE BRANDS
Back to Top