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): 091116
Company: JUBILANT GENERICS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE;ORAL Over-the-counter None No No
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter None No No
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE;ORAL Over-the-counter None No No
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;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
02/19/2015 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.

TABLET, CHEWABLE;ORAL; 5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE;ORAL Over-the-counter No 091116 JUBILANT GENERICS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE;ORAL Over-the-counter No 206793 NOVEL LABS INC
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE;ORAL Over-the-counter No 078692 SANDOZ
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE;ORAL Over-the-counter No 091116 JUBILANT GENERICS

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

TABLET, CHEWABLE;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter No 091116 JUBILANT GENERICS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter No 206793 NOVEL LABS INC
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter No 078692 SANDOZ
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter No 091116 JUBILANT GENERICS
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter Yes 021621 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.

TABLET, CHEWABLE;ORAL; 5MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE;ORAL Over-the-counter No 091116 JUBILANT GENERICS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE;ORAL Over-the-counter No 206793 NOVEL LABS INC
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE;ORAL Over-the-counter No 078692 SANDOZ
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 5MG TABLET, CHEWABLE;ORAL Over-the-counter No 091116 JUBILANT GENERICS

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

TABLET, CHEWABLE;ORAL; 10MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter No 091116 JUBILANT GENERICS
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter No 206793 NOVEL LABS INC
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter No 078692 SANDOZ
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter No 091116 JUBILANT GENERICS
CHILDREN'S ZYRTEC ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Over-the-counter Yes 021621 J AND J CONSUMER INC
Back to Top