Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 201656

Expand all

NOCTIVA (DESMOPRESSIN ACETATE)
0.00083MG/SPRAY Marketing Status: Prescription

Active Ingredient: DESMOPRESSIN ACETATE
Proprietary Name: NOCTIVA
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 0.00083MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N201656
Product Number: 001
Approval Date: Mar 3, 2017
Applicant Holder Full Name: AVADEL SPECIALTY PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NOCTIVA (DESMOPRESSIN ACETATE)
0.00166MG/SPRAY Marketing Status: Prescription

Active Ingredient: DESMOPRESSIN ACETATE
Proprietary Name: NOCTIVA
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 0.00166MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N201656
Product Number: 002
Approval Date: Mar 3, 2017
Applicant Holder Full Name: AVADEL SPECIALTY PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English