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Generated: November 16, 2018

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Details for New Drug Application (NDA): 091383

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NDA 091383 describes LORAZEPAM, which is a drug marketed by Amneal Pharms, Anda Repository, Hi-tech Pharma Co, Lupin Ltd, Pharm Assoc, Akorn, Bedford, Dava Pharms Inc, Hospira, Intl Medication Sys, Mylan Asi, Watson Labs, Watson Labs Inc, West-ward Pharms Int, Roxane, Am Therap, Ani Pharms Inc, Aurolife Pharma Llc, Halsey, Leading Pharma Llc, Mutual Pharm, Mylan, Oxford Pharms, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Warner Chilcott, and Bedford Labs, and is included in sixty-four 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-four 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 65162-687-84 30 mL in 1 BOTTLE, DROPPER (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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