Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211635

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VALTOCO (DIAZEPAM)
5MG/SPRAY
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: VALTOCO
Dosage Form; Route of Administration: SPRAY; NASAL
Strength: 5MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211635
Product Number: 001
Approval Date: Jan 10, 2020
Applicant Holder Full Name: NEURELIS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VALTOCO (DIAZEPAM)
7.5MG/SPRAY
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: VALTOCO
Dosage Form; Route of Administration: SPRAY; NASAL
Strength: 7.5MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211635
Product Number: 002
Approval Date: Jan 10, 2020
Applicant Holder Full Name: NEURELIS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VALTOCO (DIAZEPAM)
10MG/SPRAY
Marketing Status: Prescription

Active Ingredient: DIAZEPAM
Proprietary Name: VALTOCO
Dosage Form; Route of Administration: SPRAY; NASAL
Strength: 10MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211635
Product Number: 003
Approval Date: Jan 10, 2020
Applicant Holder Full Name: NEURELIS INC
Marketing Status:  Prescription
Patent and Exclusivity Information