Details for New Drug Application (NDA): 090392
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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 090392
Tradename: | LEVOCETIRIZINE DIHYDROCHLORIDE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | levocetirizine dihydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090392
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 090392
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 090392 | ANDA | Dr.Reddy's laboratories Ltd. | 55111-282 | 55111-282-01 | 100 TABLET, COATED in 1 BOTTLE (55111-282-01) |
LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 090392 | ANDA | Dr.Reddy's laboratories Ltd. | 55111-282 | 55111-282-05 | 500 TABLET, COATED in 1 BOTTLE (55111-282-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Feb 24, 2011 | TE: | AB | RLD: | No |
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