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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 eight suppliers. Additional details are available on the ATIVAN profile page.

The generic ingredient in ATIVAN is lorazepam. There are twelve drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the lorazepam profile page.

Summary for NDA: 017794

Tradename:
ATIVAN
Applicant:
Valeant Intl
Ingredient:
lorazepam
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 017794

Ingredient-typeBenzodiazepines

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 0187-0063-10 1000 TABLET in 1 BOTTLE (0187-0063-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary 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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