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FDA ANDA · ANDA065443

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

Sponsor: MYLAN PHARMS INC

APPLICATION
ANDA065443
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-11
LATEST ACTION
2018-06-01
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEPrescription
BENZOYL PEROXIDE 5%, CLINDAMYCIN PHOSPHATE EQ 1% BASE · GEL · TOPICAL

Approval history

2018-06-01Manufacturing (CMC) · Supplement 13AP
2014-09-12Manufacturing (CMC) · Supplement 4AP
2010-09-29Labeling · Supplement 3AP
2009-08-11Original — Review ↗AP
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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