Details for New Drug Application (NDA): 211983
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The generic ingredient in LEVOCETIRIZINE DIHYDROCHLORIDE is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 211983
Tradename: | LEVOCETIRIZINE DIHYDROCHLORIDE |
Applicant: | Perrigo R And D |
Ingredient: | levocetirizine dihydrochloride |
Patents: | 0 |
Pharmacology for NDA: 211983
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 211983
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 211983 | ANDA | L. Perrigo Company | 0113-0241 | 0113-0241-01 | 1 BOTTLE in 1 CARTON (0113-0241-01) / 35 TABLET, FILM COATED in 1 BOTTLE |
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 211983 | ANDA | Walgreen Company | 0363-3901 | 0363-3901-01 | 1 BOTTLE in 1 CARTON (0363-3901-01) / 35 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Mar 28, 2019 | TE: | RLD: | No |
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