FDA NDA · NDA020355

STIMATE

desmopressin acetate

Sponsor: FERRING PHARMS INC

APPLICATION

NDA020355

TYPE

NDA

ORIGINAL APPROVAL

1994-03-07

LATEST ACTION

2026-07-15

ROUTE

NASAL

DOSAGE FORM

SPRAY, METERED

MARKETING STATUS

Discontinued

Products

STIMATEDiscontinued

DESMOPRESSIN ACETATE 0.15MG/SPRAY · SPRAY, METERED · NASAL

STIMATE (NEEDS NO REFRIGERATION) · ReferenceDiscontinued

DESMOPRESSIN ACETATE 0.15MG/SPRAY · SPRAY, METERED · NASAL

2026-07-15Labeling · Supplement 22 · standard — Label ↗AP

2013-12-18Manufacturing (CMC) · Supplement 19 · standardAP

2013-06-10Labeling · Supplement 20 · standard — Letter ↗AP

2013-05-24Labeling · Supplement 17 · standard — Label ↗AP

2013-01-25Manufacturing (CMC) · Supplement 18 · standardAP

2011-09-16Labeling · Supplement 13 · standard — Letter ↗AP

2007-10-24Manufacturing (CMC) · Supplement 7 — Label ↗AP

2002-08-21Labeling · Supplement 4 · standard — Letter ↗AP

2000-03-21Manufacturing (CMC) · Supplement 3 · standardAP

1996-03-29Labeling · Supplement 2 · standardAP

1995-10-02Manufacturing (CMC) · Supplement 1 · standardAP

1994-03-07Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP

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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