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Generated: November 17, 2018

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Details for New Drug Application (NDA): 017794

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NDA 017794 describes ATIVAN, which is a drug marketed by West-ward Pharms Int and Valeant Intl and is included in two NDAs. It is available from four suppliers. Additional details are available on the ATIVAN profile page.

The generic ingredient in ATIVAN 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 017794
Tradename:ATIVAN
Applicant:Valeant Intl
Ingredient:lorazepam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017794
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 017794
Suppliers and Packaging for NDA: 017794
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATIVAN lorazepam TABLET;ORAL 017794 NDA Valeant Pharmaceuticals North America LLC 0187-0063 0187-0063-01 100 TABLET in 1 BOTTLE (0187-0063-01)
ATIVAN lorazepam TABLET;ORAL 017794 NDA Valeant Pharmaceuticals North America LLC 0187-0063 0187-0063-50 500 TABLET in 1 BOTTLE (0187-0063-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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