Details for New Drug Application (NDA): 213513
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The generic ingredient in LEVOCETIRIZINE DIHYDROCHLORIDE is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 213513
Tradename: | LEVOCETIRIZINE DIHYDROCHLORIDE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | levocetirizine dihydrochloride |
Patents: | 0 |
Pharmacology for NDA: 213513
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 213513
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 213513 | ANDA | Allegiant Health | 69168-451 | 69168-451-06 | 120 TABLET, FILM COATED in 1 BOTTLE (69168-451-06) |
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 213513 | ANDA | Allegiant Health | 69168-451 | 69168-451-60 | 60 TABLET, FILM COATED in 1 BOTTLE (69168-451-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 29, 2020 | TE: | RLD: | No |
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