Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214826

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LOREEV XR (LORAZEPAM)
1MG
Marketing Status: Prescription

Active Ingredient: LORAZEPAM
Proprietary Name: LOREEV XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214826
Product Number: 001
Approval Date: Aug 27, 2021
Applicant Holder Full Name: ALMATICA PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

LOREEV XR (LORAZEPAM)
1.5MG
Marketing Status: Prescription

Active Ingredient: LORAZEPAM
Proprietary Name: LOREEV XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 1.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214826
Product Number: 004
Approval Date: Feb 16, 2022
Applicant Holder Full Name: ALMATICA PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

LOREEV XR (LORAZEPAM)
2MG
Marketing Status: Prescription

Active Ingredient: LORAZEPAM
Proprietary Name: LOREEV XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214826
Product Number: 002
Approval Date: Aug 27, 2021
Applicant Holder Full Name: ALMATICA PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

LOREEV XR (LORAZEPAM)
3MG
Marketing Status: Prescription

Active Ingredient: LORAZEPAM
Proprietary Name: LOREEV XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214826
Product Number: 003
Approval Date: Aug 27, 2021
Applicant Holder Full Name: ALMATICA PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information