← FDA DRUG APPROVALS

FDA NDA · NDA018300

HIBISTAT

Sponsor: MOLNLYCKE HLTH

APPLICATION
NDA018300
TYPE
NDA
ORIGINAL APPROVAL
1980-05-23
LATEST ACTION
2018-04-19
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter

Products

HIBISTAT · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 0.5% · SOLUTION · TOPICAL

Approval history

2018-04-19Labeling · Supplement 19 · standard — Letter ↗AP
2012-05-24Labeling · Supplement 18 · standard — Letter ↗AP
2004-01-13Manufacturing (CMC) · Supplement 14 · standard — Letter ↗AP
2004-01-13Manufacturing (CMC) · Supplement 15 · standard — Letter ↗AP
2000-02-18Manufacturing (CMC) · Supplement 13 · standardAP
1999-10-19Manufacturing (CMC) · Supplement 12 · standardAP
1996-04-09Manufacturing (CMC) · Supplement 11 · standardAP
1994-04-14Manufacturing (CMC) · Supplement 10 · standardAP
1992-12-22Manufacturing (CMC) · Supplement 9 · standardAP
1989-09-15Manufacturing (CMC) · Supplement 8 · standardAP
1989-08-04Labeling · Supplement 6AP
1988-05-09Manufacturing (CMC) · Supplement 7 · standardAP
1985-03-04Manufacturing (CMC) · Supplement 5 · standardAP
1981-03-10Manufacturing (CMC) · Supplement 4 · standardAP
1981-01-16Manufacturing (CMC) · Supplement 3 · standardAP
1980-12-29Manufacturing (CMC) · Supplement 2 · standardAP
1980-06-26Manufacturing (CMC) · Supplement 1 · standardAP
1980-05-23Type 3 - New Dosage Form · Original · standardAP
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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