Details for New Drug Application (NDA): 203027
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The generic ingredient in LEVOCETIRIZINE DIHYDROCHLORIDE is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
Summary for 203027
Tradename: | LEVOCETIRIZINE DIHYDROCHLORIDE |
Applicant: | Apotex |
Ingredient: | levocetirizine dihydrochloride |
Patents: | 0 |
Pharmacology for NDA: 203027
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 203027
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 203027 | ANDA | Proficient Rx LP | 63187-922 | 63187-922-30 | 30 TABLET in 1 BOTTLE (63187-922-30) |
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 203027 | ANDA | Proficient Rx LP | 63187-922 | 63187-922-60 | 90 TABLET in 1 BOTTLE (63187-922-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Feb 13, 2015 | TE: | RLD: | No |
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