Details for New Drug Application (NDA): 205291
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The generic ingredient in CETIRIZINE HYDROCHLORIDE ALLERGY is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and fifty-four suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 205291
Tradename: | CETIRIZINE HYDROCHLORIDE ALLERGY |
Applicant: | Strides Pharma |
Ingredient: | cetirizine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205291
Mechanism of Action | Histamine H1 Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for 205291
Suppliers and Packaging for NDA: 205291
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | CAPSULE;ORAL | 205291 | ANDA | ASSURED / DOLLAR TREE (Greenbrier International, Inc.) | 33992-0811 | 33992-0811-2 | 1 BOTTLE, PLASTIC in 1 BOX (33992-0811-2) / 12 CAPSULE in 1 BOTTLE, PLASTIC |
CETIRIZINE HYDROCHLORIDE ALLERGY | cetirizine hydrochloride | CAPSULE;ORAL | 205291 | ANDA | Strides Pharma Inc | 59556-894 | 59556-894-12 | 1 BOTTLE in 1 CARTON (59556-894-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
Approval Date: | Jul 21, 2017 | TE: | RLD: | No |
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