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FDA NDA · NDA019955

DDAVP

desmopressin acetate

Sponsor: FERRING PHARMS INC

APPLICATION
NDA019955
TYPE
NDA
ORIGINAL APPROVAL
1995-09-06
LATEST ACTION
2014-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DDAVP · ReferencePrescription
DESMOPRESSIN ACETATE 0.1MG · TABLET · ORAL
DDAVP · ReferencePrescription
DESMOPRESSIN ACETATE 0.2MG · TABLET · ORAL

Approval history

2014-02-28Manufacturing (CMC) · Supplement 16 · standardAP
2007-10-26Labeling · Supplement 13 · standard — Label ↗AP
2005-11-10Labeling · Supplement 10 · standard — Label ↗AP
2003-11-12Labeling · Supplement 5 · standard — Letter ↗AP
2000-10-31Manufacturing (CMC) · Supplement 3 · standardAP
1999-09-24Manufacturing (CMC) · Supplement 2 · standardAP
1998-03-25Efficacy · Supplement 1 · standardAP
1995-09-06Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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