Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 218623

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LIBERVANT (DIAZEPAM)
5MG
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: LIBERVANT
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218623
Product Number: 001
Approval Date: Apr 26, 2024
Applicant Holder Full Name: AQUESTIVE THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LIBERVANT (DIAZEPAM)
7.5MG
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: LIBERVANT
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: 7.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218623
Product Number: 002
Approval Date: Apr 26, 2024
Applicant Holder Full Name: AQUESTIVE THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LIBERVANT (DIAZEPAM)
10MG
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: LIBERVANT
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218623
Product Number: 003
Approval Date: Apr 26, 2024
Applicant Holder Full Name: AQUESTIVE THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LIBERVANT (DIAZEPAM)
12.5MG
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: LIBERVANT
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: 12.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N218623
Product Number: 004
Approval Date: Apr 26, 2024
Applicant Holder Full Name: AQUESTIVE THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LIBERVANT (DIAZEPAM)
15MG
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: LIBERVANT
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218623
Product Number: 005
Approval Date: Apr 26, 2024
Applicant Holder Full Name: AQUESTIVE THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information