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FDA ANDA · ANDA206575

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

Sponsor: SUN PHARMA CANADA

APPLICATION
ANDA206575
TYPE
ANDA
ORIGINAL APPROVAL
2019-08-19
LATEST ACTION
2023-09-07
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEPrescription
BENZOYL PEROXIDE 2.5%, CLINDAMYCIN PHOSPHATE EQ 1.2% BASE · GEL · TOPICAL

Approval history

2023-09-07Labeling · Supplement 2 · standardAP
2019-08-19UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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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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