Details for New Drug Application (NDA): 018140

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NDA 018140 describes ATIVAN, which is a drug marketed by Hikma and Bausch and is included in two NDAs. It is available from three 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the lorazepam profile page.

Summary for 018140

Tradename:	ATIVAN
Applicant:	Hikma
Ingredient:	lorazepam
Patents:	0

Pharmacology for NDA: 018140

Medical Subject Heading (MeSH) Categories for 018140

Anti-Anxiety Agents
Anticonvulsants
Antiemetics
GABA Modulators
Hypnotics and Sedatives

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	Hikma Pharmaceuticals USA Inc.	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	Hikma Pharmaceuticals USA Inc.	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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	4MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Expired US Patents for NDA 018140

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Hikma	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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