Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 017794

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ATIVAN (LORAZEPAM)
0.5MG
Marketing Status: Prescription

Active Ingredient: LORAZEPAM
Proprietary Name: ATIVAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N017794
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ATIVAN (LORAZEPAM)
1MG
Marketing Status: Prescription

Active Ingredient: LORAZEPAM
Proprietary Name: ATIVAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N017794
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ATIVAN (LORAZEPAM)
2MG
Marketing Status: Prescription

Active Ingredient: LORAZEPAM
Proprietary Name: ATIVAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N017794
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information