FDA NDA · NDA020111

CHLORHEXIDINE GLUCONATE SOLUTION 0.75% ANTISEPTIC

Sponsor: BAJAJ

APPLICATION

NDA020111

TYPE

NDA

ORIGINAL APPROVAL

1997-09-11

LATEST ACTION

2019-02-22

ROUTE

TOPICAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Over-the-counter

Products

CHLORHEXIDINE GLUCONATEOver-the-counter

CHLORHEXIDINE GLUCONATE 0.75% · SOLUTION · TOPICAL

2019-02-22Labeling · Supplement 13 · standard — Letter ↗AP

2017-11-20Labeling · Supplement 9 · standard — Label ↗AP

2013-05-08Labeling · Supplement 7 · standard — Label ↗AP

1999-10-08Manufacturing (CMC) · Supplement 2 · standardAP

1998-04-16Manufacturing (CMC) · Supplement 1 · standardAP

1997-09-11Type 3 - New Dosage Form · Original · standardAP

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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