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FDA ANDA · ANDA091345

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA091345
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-03
LATEST ACTION
2019-10-25
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Prescription

Products

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)Prescription
DESMOPRESSIN ACETATE 0.01MG/SPRAY · SPRAY, METERED · NASAL

Approval history

2019-10-25Labeling · Supplement 1 · standardAP
2017-10-03OriginalAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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