Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050441
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLEOCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription AP 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
10/02/1972 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/19/2019 SUPPL-81 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050441s081,050639s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050441Orig1s081, 050639Orig1s040ltr.pdf
04/16/2018 SUPPL-79 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050441s079,050639s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050441Orig1s079,050639Orig1s038ltr.pdf
05/02/2017 SUPPL-78 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050441Orig1s076,s078,050639Orig1s035,s037ltr.pdf
05/02/2017 SUPPL-76 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050441Orig1s076,s078,050639Orig1s035,s037ltr.pdf
08/05/2016 SUPPL-73 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/2016/050441s073,050639s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s073,050639Orig1s034ltr.pdf
08/05/2016 SUPPL-72 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s072,050639s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s072,050639Orig1s033ltr.pdf
03/24/2016 SUPPL-71 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s071,050639Orig1s031ltr.pdf
10/20/2014 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

06/10/2014 SUPPL-68 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s068ltr.pdf
06/10/2014 SUPPL-67 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s068ltr.pdf
06/10/2014 SUPPL-66 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050441Orig1s066,s067,s068ltr.pdf
12/18/2012 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

06/07/2011 SUPPL-61 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050162s090,050441s061,050639s022ltr.pdf
10/15/2010 SUPPL-59 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050441s059ltr.pdf
04/14/2008 SUPPL-55 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s055,050639s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050441s055,050639s016ltr.pdf
02/21/2008 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s053,050639s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050441s053ltr.pdf
01/28/2004 SUPPL-48 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162slr084,50441slr048,50639slr014ltr.pdf
11/21/2001 SUPPL-47 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50441s47lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50441s47ltr.pdf
04/03/2000 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

09/29/2004 SUPPL-45 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162s082,50441s045,50639s013ltr.pdf
12/12/1997 SUPPL-44 Labeling

Label is not available on this site.

07/17/1997 SUPPL-43 Labeling

Label is not available on this site.

02/21/1995 SUPPL-42 Labeling

Label is not available on this site.

12/20/1995 SUPPL-41 Labeling

Label is not available on this site.

03/05/1996 SUPPL-40 Labeling

Label is not available on this site.

03/17/1997 SUPPL-38 Labeling

Label is not available on this site.

03/23/1993 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1991 SUPPL-35 Labeling

Label is not available on this site.

03/17/1997 SUPPL-25 Labeling

Label is not available on this site.

03/17/1997 SUPPL-23 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/19/2019 SUPPL-81 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050441s081,050639s040lbl.pdf
04/16/2018 SUPPL-79 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050441s079,050639s038lbl.pdf
05/02/2017 SUPPL-78 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf
05/02/2017 SUPPL-76 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf
08/05/2016 SUPPL-73 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/2016/050441s073,050639s034lbl.pdf
08/05/2016 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s072,050639s033lbl.pdf
03/24/2016 SUPPL-71 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s071lbl.pdf
06/10/2014 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf
06/10/2014 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf
06/10/2014 SUPPL-66 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050441Orig1s066, s067, s068lbl.pdf
04/14/2008 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s055,050639s016lbl.pdf
02/21/2008 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s053,050639s015lbl.pdf
09/29/2004 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf
11/21/2001 SUPPL-47 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50441s47lbl.pdf

CLEOCIN PHOSPHATE

INJECTABLE;INJECTION; EQ 150MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 050441 PHARMACIA AND UPJOHN
CLEOCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062803 PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062800 ALVOGEN INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062801 ALVOGEN INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062943 ALVOGEN INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 065346 FRESENIUS KABI USA
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 065347 FRESENIUS KABI USA
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204748 MYLAN LABS LTD
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 204749 MYLAN LABS LTD
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 090108 SAGENT PHARMS INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 090109 SAGENT PHARMS INC
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062889 WEST-WARD PHARMS INT
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 150MG BASE/ML INJECTABLE;INJECTION Prescription No AP 065206 WEST-WARD PHARMS INT

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