Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050537
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLEOCIN CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB;TOPICAL Prescription AT Yes No
CLEOCIN T CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;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
07/09/1980 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
04/19/2019 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s040,050600s017,050615s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050537Orig1s040,050600Orig1s017,050615Orig1s018ltr.pdf
11/16/2017 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050537s039,050600s016,050615s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050537Orig1s039,050600Orig1s016,050615Orig1s016ltr.pdf
01/15/2016 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,050615s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050537s037,050600s014,050615s014ltr.pdf
08/29/2014 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/04/2014 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,050615s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050600Orig1s013,050537Orig1s035,050615Orig1s012ltr.pdf
05/30/2003 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50537slr026,50600slr007,50615slr005ltr.pdf
06/07/1999 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/05/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/21/1981 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/25/1982 SUPPL-21 Labeling

Label is not available on this site.

11/23/1981 SUPPL-19 Labeling

Label is not available on this site.

11/18/1981 SUPPL-18 Labeling

Label is not available on this site.

12/21/1992 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/22/1994 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/2002 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50537slr013,50600slr002,50615slr003ltr.pdf
07/28/1989 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/15/1989 SUPPL-10 Labeling

Label is not available on this site.

04/20/1981 SUPPL-9 Labeling

Label is not available on this site.

05/11/1981 SUPPL-8 Labeling

Label is not available on this site.

01/23/1986 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1984 SUPPL-6 Labeling

Label is not available on this site.

07/18/1986 SUPPL-5 Labeling

Label is not available on this site.

03/02/1983 SUPPL-4 Labeling

Label is not available on this site.

09/30/1980 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/15/1980 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/14/1980 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/19/2019 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050537s040,050600s017,050615s018lbl.pdf
11/16/2017 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050537s039,050600s016,050615s016lbl.pdf
01/15/2016 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,050615s014lbl.pdf
04/04/2014 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,050615s012lbl.pdf
05/30/2003 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf
07/14/2002 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf

CLEOCIN

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB;TOPICAL Prescription Yes AT 050537 PHARMACIA AND UPJOHN
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 PERRIGO NEW YORK
CLINDETS CLINDAMYCIN PHOSPHATE EQ 1% BASE SWAB;TOPICAL Prescription No AT 064136 PERRIGO CO

CLEOCIN T

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN T CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription Yes AT 050537 PHARMACIA AND UPJOHN
CLINDA-DERM CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 063329 PADDOCK LLC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 208767 CADILA
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 209914 ENCUBE ETHICALS
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 065254 FOUGERA PHARMS
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 064159 FOUGERA PHARMS INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 062811 G AND W LABS INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 209846 GLASSHOUSE PHARMS
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 064050 PERRIGO NEW YORK
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 065184 TARO PHARM INDS
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 206945 TELIGENT PHARMA INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL Prescription No AT 203343 VINTAGE PHARMS

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