Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050639
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes Yes
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription AP Yes Yes
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 18MG 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
08/30/1989 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
06/19/2019 SUPPL-40 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-38 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-37 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/label/2017/050441s076s078,050639s035s037lbl.pdf
05/02/2017 SUPPL-35 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/label/2017/050441s076s078,050639s035s037lbl.pdf
08/05/2016 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s073,050639s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050441Orig1s073,050639Orig1s034ltr.pdf
08/05/2016 SUPPL-33 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
05/20/2016 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/24/2016 SUPPL-31 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
09/18/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

06/25/2014 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf
06/25/2014 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf
06/25/2014 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050639Orig1s027,s028,s029ltr.pdf
10/09/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

06/26/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

06/07/2011 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050162s090,050441s061,050639s022ltr.pdf
04/14/2008 SUPPL-16 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-15 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/2008/050639s015ltr.pdf
01/28/2004 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162slr084,50441slr048,50639slr014ltr.pdf
09/29/2004 SUPPL-13 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-12 Labeling

Label is not available on this site.

07/17/1997 SUPPL-11 Labeling

Label is not available on this site.

03/09/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/21/1995 SUPPL-9 Labeling

Label is not available on this site.

04/05/1993 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1995 SUPPL-7 Labeling

Label is not available on this site.

03/17/1997 SUPPL-5 Labeling

Label is not available on this site.

05/21/1992 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/11/1991 SUPPL-2 Labeling

Label is not available on this site.

04/18/1991 SUPPL-1 Manufacturing (CMC)

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-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050441s081,050639s040lbl.pdf
04/16/2018 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050441s079,050639s038lbl.pdf
05/02/2017 SUPPL-37 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-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050441s076s078,050639s035s037lbl.pdf
08/05/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s073,050639s034lbl.pdf
08/05/2016 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s072,050639s033lbl.pdf
03/24/2016 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050441s071lbl.pdf
06/25/2014 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf
06/25/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf
06/25/2014 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050639s027s028s029lbl.pdf
04/14/2008 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s055,050639s016lbl.pdf
02/21/2008 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050441s053,050639s015lbl.pdf
09/29/2004 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; EQ 6MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 050639 PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203048 AKORN INC
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription No AP 208084 BAXTER HLTHCARE CORP
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 6MG BASE/ML INJECTABLE;INJECTION Prescription No AP 201692 SANDOZ INC

INJECTABLE;INJECTION; EQ 12MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 050639 PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203048 AKORN INC
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription No AP 208084 BAXTER HLTHCARE CORP
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 12MG BASE/ML INJECTABLE;INJECTION Prescription No AP 201692 SANDOZ INC

INJECTABLE;INJECTION; EQ 18MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 050639 PHARMACIA AND UPJOHN
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203048 AKORN INC
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE;INJECTION Prescription No AP 208084 BAXTER HLTHCARE CORP
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER CLINDAMYCIN PHOSPHATE EQ 18MG BASE/ML INJECTABLE;INJECTION Prescription No AP 201692 SANDOZ INC

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