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Accenture
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Generated: August 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071195

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NDA 071195 describes LORAZEPAM, which is a drug marketed by Hospira, Leading Pharma Llc, Lupin Ltd, Watson Labs, Sagent Agila Llc, Akorn, Amneal Pharms, Am Therap, Halsey, Watson Labs Inc, Warner Chilcott, Usl Pharma, Sandoz, 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, West-ward Pharms Int, Ani Pharms Inc, and Bedford Labs, and is included in sixty-seven NDAs. It is available from fifty-two suppliers. Additional details are available on the LORAZEPAM profile page.

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

Summary for NDA: 071195

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 071195

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 071195

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORAZEPAM
lorazepam
TABLET;ORAL 071195 ANDA Rebel Distributors Corp 21695-240 21695-240-03 3 TABLET in 1 BOTTLE (21695-240-03)
LORAZEPAM
lorazepam
TABLET;ORAL 071195 ANDA Rebel Distributors Corp 21695-240 21695-240-30 30 TABLET in 1 BOTTLE (21695-240-30)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2MG
Approval Date:Apr 15, 1988TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

UBS
US Department of Justice
US Army
Fish and Richardson
Daiichi Sankyo
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Citi

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