Details for New Drug Application (NDA): 205564
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NDA 205564 describes LEVOCETIRIZINE DIHYDROCHLORIDE, which is a drug marketed by Apotex, Chartwell Molecular, Padagis Us, Taro, Dr Reddys, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules, Hetero Labs Ltd Iii, Ipca Labs Ltd, Macleods Pharms Ltd, Micro Labs, Micro Labs Ltd India, Perrigo R And D, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds Ltd, Synthon Pharms, Teva Pharms, and Us Antibiotics, and is included in twenty-three NDAs. It is available from forty-nine suppliers. Additional details are available on the LEVOCETIRIZINE DIHYDROCHLORIDE profile page.
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.
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 205564
| Tradename: | LEVOCETIRIZINE DIHYDROCHLORIDE |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | levocetirizine dihydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 205564
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 205564
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 205564 | ANDA | Macleods Pharmaceuticals Limited | 33342-200 | 33342-200-07 | 30 TABLET, FILM COATED in 1 BOTTLE (33342-200-07) |
| LEVOCETIRIZINE DIHYDROCHLORIDE | levocetirizine dihydrochloride | TABLET;ORAL | 205564 | ANDA | Macleods Pharmaceuticals Limited | 33342-200 | 33342-200-10 | 90 TABLET, FILM COATED in 1 BOTTLE (33342-200-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 11, 2016 | TE: | AB | RLD: | No | ||||
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