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Generated: December 10, 2017

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, Sagent Agila Llc, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Roxane, Am Therap, Anda Repository, Ani Pharms Inc, 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-seven NDAs. It is available from fifty-one 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-four suppliers are listed for this compound. Additional details are available on the lorazepam profile page.

Summary for 091383

Tradename:1
Applicant:1
Ingredient:1
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 65162-687-84 30 mL in 1 BOTTLE, DROPPER (65162-687-84)

Summary for product number 001

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


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