Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090785
Company: PERRIGO UK FINCO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE 1% AEROSOL, FOAM;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
03/31/2010 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090785s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/090785Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2012 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

CLINDAMYCIN PHOSPHATE

AEROSOL, FOAM;TOPICAL; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE 1% AEROSOL, FOAM;TOPICAL Prescription No AT 090785 PERRIGO UK FINCO
EVOCLIN CLINDAMYCIN PHOSPHATE 1% AEROSOL, FOAM;TOPICAL Prescription Yes AT 050801 MYLAN

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