Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050801
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EVOCLIN CLINDAMYCIN PHOSPHATE 1% AEROSOL, FOAM;TOPICAL Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/22/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21709lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21709ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050801s000_EvoclinTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/17/2018 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050801s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050801Orig1s018ltr.pdf
01/20/2015 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/20/2012 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050801s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050801s015ltr.pdf
12/21/2010 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050801s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050801s011ltr.pdf
07/11/2006 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050801s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050801s006LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/17/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050801s018lbl.pdf
01/20/2012 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050801s015lbl.pdf
12/21/2010 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050801s011lbl.pdf
07/11/2006 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050801s006lbl.pdf
10/22/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21709lbl.pdf

EVOCLIN

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 210778 GLENMARK PHARMS LTD
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE 1% AEROSOL, FOAM;TOPICAL Prescription No AT 090785 PADAGIS ISRAEL
EVOCLIN CLINDAMYCIN PHOSPHATE 1% AEROSOL, FOAM;TOPICAL Prescription Yes AT 050801 MYLAN

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