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Details for New Drug Application (NDA): 090199

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NDA 090199 describes LEVOCETIRIZINE DIHYDROCHLORIDE, which is a drug marketed by Apotex Inc, Synthon Pharms, Micro Labs Ltd India, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Sun Pharma Global, L Perrigo Co, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Taro Pharm Inds, Glenmark Generics, Sandoz, Dr Reddys Labs Ltd, and Teva Pharms, and is included in fifteen NDAs. It is available from twenty-four 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the levocetirizine dihydrochloride profile page.

Summary for NDA: 090199

Teva Pharms
levocetirizine dihydrochloride
Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 090199

Suppliers and Packaging for NDA: 090199

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
levocetirizine dihydrochloride
TABLET;ORAL 090199 ANDA Teva Pharmaceuticals USA Inc 0093-7701 0093-7701-98 90 TABLET, FILM COATED in 1 BOTTLE (0093-7701-98)
levocetirizine dihydrochloride
TABLET;ORAL 090199 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-784 35356-784-30 30 TABLET, FILM COATED in 1 BOTTLE (35356-784-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 22, 2011TE:ABRLD:No

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