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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 201656

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NOCTIVA (DESMOPRESSIN ACETATE)
0.00083MG/SPRAY
Marketing Status: Discontinued
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: ACERUS PHARMACEUTICALS USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
NOCTIVA (DESMOPRESSIN ACETATE)
0.00166MG/SPRAY
Marketing Status: Discontinued
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: No
TE Code: 
Application Number: N201656
Product Number: 002
Approval Date: Mar 3, 2017
Applicant Holder Full Name: ACERUS PHARMACEUTICALS USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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