← FDA DRUG APPROVALS

FDA ANDA · ANDA065139

CLINDAMYCIN PHOSPHATE

Sponsor: FOUGERA PHARMS

APPLICATION
ANDA065139
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-27
LATEST ACTION
2023-02-08
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

CLINDAMYCIN PHOSPHATEPrescription
CLINDAMYCIN PHOSPHATE EQ 2% BASE · CREAM · VAGINAL

Approval history

2023-02-08Labeling · Supplement 9 · standardAP
2023-02-08Labeling · Supplement 12 · standardAP
2023-02-08Labeling · Supplement 10 · standardAP
2023-02-08Labeling · Supplement 8 · standardAP
2004-12-27OriginalLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →