Details for New Drug Application (NDA): 204599
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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 204599
Tradename: | LEVOCETIRIZINE DIHYDROCHLORIDE |
Applicant: | Chartwell Molecular |
Ingredient: | levocetirizine dihydrochloride |
Patents: | 0 |
Pharmacology for NDA: 204599
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 204599
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | SOLUTION;ORAL | 204599 | ANDA | Chartwell RX, LLC | 62135-917 | 62135-917-38 | 148 mL in 1 BOTTLE (62135-917-38) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 2.5MG/5ML | ||||
Approval Date: | May 15, 2017 | TE: | AA | RLD: | No |
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