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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065513
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB;TOPICAL Prescription AT No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/17/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/22/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

CLINDAMYCIN PHOSPHATE

SWAB;TOPICAL; EQ 1% BASE
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB;TOPICAL Prescription No AT 065513 AKORN
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB;TOPICAL Prescription No AT 065049 PADAGIS US
CLINDETS CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB;TOPICAL Prescription No AT 064136 PADAGIS US
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