CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY از شرکت QUAGEN

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
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CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY از شرکت QUAGEN

Abbreviated New Drug Application (ANDA): 212266

Company: QUAGEN

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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/16/2019 ORIG-1 Approval

STANDARD

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212266s000lbl.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/16/2019 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212266s000lbl.pdf

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 091327 ATHEM
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 210622 HETERO LABS LTD III
CHILDREN’S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 091130 LANNETT CO INC
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 ALLERGY CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090572 TRIS PHARMA INC
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 091327 ATHEM
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 091130 LANNETT CO INC
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 CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG/5ML SYRUP;ORAL Over-the-counter No 090572 TRIS PHARMA INC
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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