Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050680
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLEOCIN CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM;VAGINAL Discontinued None No No
CLEOCIN CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM;VAGINAL Prescription AB 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
08/11/1992 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/21/2019 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050680s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050680Orig1s017ltr.pdf
12/20/2018 SUPPL-16 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050680s016,050767s015lbl.pdf
09/08/2017 SUPPL-13 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-11 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-10 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
08/20/2003 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50680slr004_cleocin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50680slr004ltr.pdf
08/05/1996 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/02/1998 SUPPL-2 Efficacy-New Dosing Regimen Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050680s002_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050680S002.cfm
10/05/1995 SUPPL-1 Efficacy-New Indication

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/21/2019 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050680s017lbl.pdf
12/20/2018 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050680s016,050767s015lbl.pdf
09/08/2017 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050680s013,050767s014lbl.pdf
07/13/2015 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050680s011,050767s012lbl.pdf
05/09/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf
05/09/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf
08/20/2003 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50680slr004_cleocin_lbl.pdf

CLEOCIN

CREAM;VAGINAL; EQ 2% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM;VAGINAL Prescription Yes AB 050680 PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 2% BASE CREAM;VAGINAL Prescription No AB 065139 FOUGERA PHARMS

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