Details for New Drug Application (NDA): 090229
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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 090229
Tradename: | LEVOCETIRIZINE DIHYDROCHLORIDE |
Applicant: | Synthon Pharms |
Ingredient: | levocetirizine dihydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090229
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 090229
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 090229 | ANDA | Proficient Rx LP | 71205-204 | 71205-204-30 | 30 TABLET in 1 BOTTLE (71205-204-30) |
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 090229 | ANDA | Proficient Rx LP | 71205-204 | 71205-204-60 | 60 TABLET in 1 BOTTLE (71205-204-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 26, 2010 | TE: | AB | RLD: | No |
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