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Generated: November 20, 2018

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Details for New Drug Application (NDA): 018140

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NDA 018140 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 018140
Tradename:ATIVAN
Applicant:West-ward Pharms Int
Ingredient:lorazepam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018140
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 018140
Suppliers and Packaging for NDA: 018140
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATIVAN lorazepam INJECTABLE;INJECTION 018140 NDA West-Ward Pharmaceuticals Corp. 0641-6000 0641-6000-10 10 VIAL in 1 CARTON (0641-6000-10) > 10 mL in 1 VIAL (0641-6000-01)
ATIVAN lorazepam INJECTABLE;INJECTION 018140 NDA West-Ward Pharmaceuticals Corp. 0641-6001 0641-6001-25 25 VIAL in 1 CARTON (0641-6001-25) > 1 mL in 1 VIAL (0641-6001-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength4MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Expired US Patents for NDA 018140

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
West-ward Pharms Int ATIVAN lorazepam INJECTABLE;INJECTION 018140-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
West-ward Pharms Int ATIVAN lorazepam INJECTABLE;INJECTION 018140-002 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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