Details for New Drug Application (NDA): 090199
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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 090199
Tradename: | LEVOCETIRIZINE DIHYDROCHLORIDE |
Applicant: | Teva Pharms |
Ingredient: | levocetirizine dihydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090199
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 090199
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 090199 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7701 | 0093-7701-98 | 90 TABLET, FILM COATED in 1 BOTTLE (0093-7701-98) |
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 090199 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-479 | 43063-479-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-479-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 22, 2011 | TE: | AB | RLD: | No |
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