Details for New Drug Application (NDA): 210914
✉ Email this page to a colleague
The generic ingredient in LEVOCETIRIZINE HYDROCHLORIDE 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 210914
Tradename: | LEVOCETIRIZINE HYDROCHLORIDE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | levocetirizine dihydrochloride |
Patents: | 0 |
Pharmacology for NDA: 210914
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 210914
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOCETIRIZINE HYDROCHLORIDE | levocetirizine dihydrochloride | SOLUTION;ORAL | 210914 | ANDA | Camber Pharmaceuticals, Inc. | 31722-659 | 31722-659-31 | 1 BOTTLE in 1 CARTON (31722-659-31) / 148 mL in 1 BOTTLE |
LEVOCETIRIZINE HYDROCHLORIDE | levocetirizine dihydrochloride | SOLUTION;ORAL | 210914 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-2836 | 68071-2836-8 | 1 BOTTLE in 1 CARTON (68071-2836-8) / 148 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 2.5MG/5ML | ||||
Approval Date: | Apr 1, 2019 | TE: | AA | RLD: | No |
Complete Access Available with Subscription