Application Nr Approved Date Route Status External Links
ANDA078271 None Nasal None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications & Usage Desmopressin Acetate Nasal Solution 0.01% (Nasal Spray) Is Indicated As Antidiuretic Replacement Therapy In The Management Of Central Diabetes Insipidus In Adults And Pediatric Patients 4 Years Of Age And Older. Limitations Of Use: Desmopressin Acetate Nasal Solution 0.01% (Nasal Spray) Is Not Indicated For: • Treatment Of Nephrogenic Diabetes Insipidus, • Treatment Of Primary Nocturnal Enuresis [See Warnings And Precautions (5.1)], • Use In Patients With Conditions That Compromise The Intranasal Route Of Administration (E.g., Severe Nasal Congestion And Blockage, Nasal Mucosa Atrophy, Severe Atrophic Rhinitis, Recent Nasal Surgery Such As Transsphenoidal Hypophysectomy) [See Warnings And Precautions (5.2)]. • Use In Patients With An Impaired Level Of Consciousness, • Use In Patients Requiring Doses Less Than 10 Mcg Or Doses That Are Not Multiples Of 10 Mcg [See Dosage Forms And Strengths (3)]. Desmopressin Acetate Is A Vasopressin Analog Indicated As Antidiuretic Replacement Therapy In The Management Of Central Diabetes Insipidus For Adults And Pediatric Patients 4 Years Of Age And Older (1) Limitations Of Use: Desmopressin Acetate Is Not Indicated For: Treatment Of Nephrogenic Diabetes Insipidus (1) Treatment Of Primary Nocturnal Enuresis (1, 5.1) Use In Patients With Conditions That Compromise Intranasal Route Of Administration (1, 5.2) Use In Patients With An Impaired Level Of Consciousness (1) Use In Patients Requiring Doses Less Than 10 Mcg Or Doses That Are Not Multiples Of 10 Mcg (1,3)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Desmopressin Acetate

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