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FDA ANDA · ANDA075220

DESMOPRESSIN ACETATE

Sponsor: HOSPIRA

APPLICATION
ANDA075220
TYPE
ANDA
ORIGINAL APPROVAL
2000-08-28
LATEST ACTION
2019-07-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DESMOPRESSIN ACETATEDiscontinued
DESMOPRESSIN ACETATE 0.004MG/ML · INJECTABLE · INJECTION

Approval history

2019-07-29Labeling · Supplement 20 · standardAP
2008-06-04Labeling · Supplement 18AP
2008-03-24Labeling · Supplement 14AP
2007-09-23Labeling · Supplement 17AP
2005-04-20Labeling · Supplement 8AP
2002-09-06Manufacturing (CMC) · Supplement 3AP
2002-01-15Manufacturing (CMC) · Supplement 2AP
2002-01-15Manufacturing (CMC) · Supplement 1AP
2000-08-28Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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