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FDA ANDA · ANDA065184

CLINDAMYCIN PHOSPHATE

Sponsor: TARO PHARM INDS

APPLICATION
ANDA065184
TYPE
ANDA
ORIGINAL APPROVAL
2004-03-31
LATEST ACTION
2019-08-16
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CLINDAMYCIN PHOSPHATEPrescription
CLINDAMYCIN PHOSPHATE EQ 1% BASE · SOLUTION · TOPICAL

Approval history

2019-08-16Labeling · Supplement 9 · standardAP
2016-09-01Labeling · Supplement 4 · standardAP
2016-09-01Labeling · Supplement 3 · standardAP
2004-03-31OriginalReviewAP
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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