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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022517

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NOCDURNA (DESMOPRESSIN ACETATE)
0.0277MG
Marketing Status: Prescription
Active Ingredient: DESMOPRESSIN ACETATE
Proprietary Name: NOCDURNA
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: 0.0277MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022517
Product Number: 001
Approval Date: Jun 21, 2018
Applicant Holder Full Name: FERRING PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
NOCDURNA (DESMOPRESSIN ACETATE)
0.0553MG
Marketing Status: Prescription
Active Ingredient: DESMOPRESSIN ACETATE
Proprietary Name: NOCDURNA
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: 0.0553MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022517
Product Number: 002
Approval Date: Jun 21, 2018
Applicant Holder Full Name: FERRING PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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