Details for New Drug Application (NDA): 210914
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NDA 210914 describes LEVOCETIRIZINE HYDROCHLORIDE, which is a drug marketed by Hetero Labs Ltd Iii and is included in one NDA. It is available from one supplier. Additional details are available on the LEVOCETIRIZINE HYDROCHLORIDE profile page.
The generic ingredient in LEVOCETIRIZINE HYDROCHLORIDE is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.
The generic ingredient in LEVOCETIRIZINE HYDROCHLORIDE is levocetirizine dihydrochloride. There are thirteen drug master file entries for this compound. Fifty-one 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 |
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 | ||||
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