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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201546
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter None No No
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;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
05/20/2011 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/06/2015 SUPPL-2 Labeling-Container/Carton Labels

Label is not available on this site.

07/07/2011 SUPPL-1 Labeling-Container/Carton Labels

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.

SYRUP;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 SYRUP;ORAL Over-the-counter No 090765 AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090750 AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091327 BAJAJ
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091130 CHARTWELL MOLECULAR
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 210622 HETERO LABS LTD III
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090254 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 204226 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 212266 QUAGEN
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090182 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 201546 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090765 AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090750 AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091327 BAJAJ
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091130 CHARTWELL MOLECULAR
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090254 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090182 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 201546 TARO
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter Yes 022155 J AND J CONSUMER INC
CHILDREN'S ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter Yes 022155 J AND J CONSUMER INC

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.

SYRUP;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 SYRUP;ORAL Over-the-counter No 090765 AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090750 AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091327 BAJAJ
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091130 CHARTWELL MOLECULAR
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 210622 HETERO LABS LTD III
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090254 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 204226 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 212266 QUAGEN
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090182 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 201546 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090765 AMNEAL PHARMS
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090750 AUROBINDO PHARMA
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091327 BAJAJ
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091130 CHARTWELL MOLECULAR
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090254 PERRIGO R AND D
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090182 TARO
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 201546 TARO
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter Yes 022155 J AND J CONSUMER INC
CHILDREN'S ZYRTEC HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter Yes 022155 J AND J CONSUMER INC
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