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Details for New Drug Application (NDA): 071118

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NDA 071118 describes LORAZEPAM, which is a drug marketed by Hospira, Leading Pharma Llc, Sandoz, Lupin Ltd, Watson Labs, Akorn, Amneal Pharms, Am Therap, Halsey, Watson Labs Inc, Warner Chilcott, Usl Pharma, Paddock Llc, Sun Pharm Inds Ltd, Superpharm, Roxane, Intl Medication Sys, Frontida Biopharm, Vintage Pharms, Mylan, Pharm Assoc, Hi-tech Pharma Co, Mutual Pharm, Par Pharm, Bedford, Dava Pharms Inc, Eurohlth Intl Sarl, Ani Pharms Inc, and Bedford Labs, and is included in sixty-seven NDAs. It is available from fifty-four suppliers. Additional details are available on the LORAZEPAM profile page.

The generic ingredient in LORAZEPAM is lorazepam. There are twelve drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the lorazepam profile page.

Summary for NDA: 071118

Tradename:
LORAZEPAM
Applicant:
Watson Labs
Ingredient:
lorazepam
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 071118

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 071118

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORAZEPAM
lorazepam
TABLET;ORAL 071118 ANDA bryant ranch prepack 63629-1233 63629-1233-0 10 TABLET in 1 BOTTLE (63629-1233-0)
LORAZEPAM
lorazepam
TABLET;ORAL 071118 ANDA bryant ranch prepack 63629-1233 63629-1233-1 30 TABLET in 1 BOTTLE (63629-1233-1)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG
Approval Date:Jul 24, 1986TE:RLD:No


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