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FDA ANDA · ANDA209914

CLINDAMYCIN PHOAPHATE TOPICAL SOLUTION USP, 1%

clindamycin phosphate topical solution usp, 1%

Sponsor: ENCUBE ETHICALS

APPLICATION
ANDA209914
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-28
LATEST ACTION
2021-03-18
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

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

Approval history

2021-03-18Manufacturing (CMC) · Supplement 3 · unknownAP
2020-02-12Labeling · Supplement 2 · standardAP
2020-02-12Labeling · Supplement 1 · standardAP
2019-01-28UNKNOWN · Original · standardAP
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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