Details for New Drug Application (NDA): 202673
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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 202673
Tradename: | LEVOCETIRIZINE DIHYDROCHLORIDE |
Applicant: | Taro |
Ingredient: | levocetirizine dihydrochloride |
Patents: | 0 |
Pharmacology for NDA: 202673
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 202673
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | SOLUTION;ORAL | 202673 | ANDA | Taro Pharmaceuticals U.S.A., inc. | 51672-4161 | 51672-4161-1 | 1 BOTTLE in 1 CARTON (51672-4161-1) / 237 mL in 1 BOTTLE |
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | SOLUTION;ORAL | 202673 | ANDA | Taro Pharmaceuticals U.S.A., inc. | 51672-4161 | 51672-4161-4 | 1 BOTTLE in 1 CARTON (51672-4161-4) / 59 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 2.5MG/5ML | ||||
Approval Date: | Jul 26, 2013 | TE: | AA | RLD: | No |
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