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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Cerilliant
Colorcon
Fuji
Moodys
Baxter
Medtronic
Julphar
Queensland Health

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091383

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NDA 091383 describes LORAZEPAM, which is a drug marketed by Amneal Pharms, Hi-tech Pharma Co, Lupin Ltd, Pharm Assoc, Saptalis Pharms, Akorn, Bedford, Dava Pharms Inc, Hospira, Intl Medication Sys, Mylan Asi, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Roxane, Am Therap, Anda Repository, Ani Pharms Inc, Aurolife Pharma Llc, Halsey, Leading Pharma Llc, Mutual Pharm, Mylan, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Vintage Pharms, Warner Chilcott, and Bedford Labs, and is included in sixty-six NDAs. It is available from fifty 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-two suppliers are listed for this compound. Additional details are available on the lorazepam profile page.
Summary for 091383
Tradename:LORAZEPAM
Applicant:Amneal Pharms
Ingredient:lorazepam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091383
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 091383
Suppliers and Packaging for NDA: 091383
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORAZEPAM lorazepam CONCENTRATE;ORAL 091383 ANDA Amneal Pharmaceuticals, LLC 65162-687 N 65162-687-84

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength2MG/ML
Approval Date:Dec 23, 2009TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Julphar
Daiichi Sankyo
UBS
Queensland Health
McKinsey
Cerilliant
Cantor Fitzgerald
US Department of Justice

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