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. Forty-eight 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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