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Daiichi Sankyo
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Moodys
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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078203

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NDA 078203 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 thirty-six 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the lorazepam profile page.
Summary for 078203
Tradename:LORAZEPAM
Applicant:Leading Pharma Llc
Ingredient:lorazepam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078203
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 078203
Suppliers and Packaging for NDA: 078203
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORAZEPAM lorazepam TABLET;ORAL 078203 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8075 N 0615-8075-39
LORAZEPAM lorazepam TABLET;ORAL 078203 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8076 N 0615-8076-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jul 30, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jul 30, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jul 30, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
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McKesson
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Healthtrust
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McKinsey

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