Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050767
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLEOCIN CLINDAMYCIN PHOSPHATE 100MG SUPPOSITORY;VAGINAL Prescription None 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
08/13/1999 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50767lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50767ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50767_Cleocin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/16/2019 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050767s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050767Orig1s016ltr.pdf
12/20/2018 SUPPL-15 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050680s016,050767s015lbl.pdf
09/08/2017 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050680s013,050767s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050680Orig1s013,050767Orig1s014ltr.pdf
07/13/2015 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050680s011,050767s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050680Orig1s011,050767Orig1s012ltr.pdf
05/09/2014 SUPPL-11 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050680Orig1s010,050767Orig1s011ltr.pdf
06/19/2013 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050767s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050767Orig1s010ltr.pdf
05/15/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/16/2019 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050767s016lbl.pdf
12/20/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050680s016,050767s015lbl.pdf
09/08/2017 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050680s013,050767s014lbl.pdf
07/13/2015 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050680s011,050767s012lbl.pdf
05/09/2014 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf
05/09/2014 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf
06/19/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050767s010lbl.pdf
08/13/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50767lbl.pdf

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