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CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2016-03-08
Drug application
- FDA Application #
ANDA206793- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
- Generic name
- Cetirizine Hydrochloride
- Active ingredients
- CETIRIZINE HYDROCHLORIDE
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- NOVEL LABS INC
- First approval
- 2016-03-08
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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