Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019281
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYKLOKAPRON TRANEXAMIC ACID 100MG/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
12/30/1986 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/21/2017 SUPPL-41 Labeling, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019281s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019281Orig1s041ltr.pdf
08/01/2016 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

11/03/2016 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

02/01/2016 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

10/20/2015 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/01/2015 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/17/2015 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

12/15/2014 SUPPL-33 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019281s033lbl.pdf
05/10/2013 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019281s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019281Orig1s031ltr.pdf
01/25/2011 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019281s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019281s030ltr.pdf
01/28/2009 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019281s027ltr.pdf
12/22/2008 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019281s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019281s025ltr.pdf
05/15/2002 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/16/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/2001 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/02/2001 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/31/2001 SUPPL-15 Labeling

Label is not available on this site.

03/27/2001 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19281S13LTR.PDF
07/31/2001 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/28/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1999 SUPPL-9 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19281-S008_Cyklokapron.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19281-S008_Cyklokapron.pdf
07/24/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/24/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1994 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/24/1996 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1994 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/24/1996 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
11/21/2017 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019281s041lbl.pdf
11/21/2017 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019281s041lbl.pdf
12/15/2014 SUPPL-33 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019281s033lbl.pdf
05/10/2013 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019281s031lbl.pdf
01/25/2011 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019281s030lbl.pdf
12/22/2008 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019281s025lbl.pdf

CYKLOKAPRON

INJECTABLE;INJECTION; 100MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYKLOKAPRON TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription Yes AP 019281 PHARMACIA AND UPJOHN
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 202436 ACIC PHARMS
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 209326 ACIC PHARMS
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 202373 AKORN
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 206594 AKORN
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 206634 AKORN
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 208840 AMNEAL PHARMS CO
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 212676 APOLLO PHARMS INC
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 205035 AUROBINDO PHARMA LTD
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 212360 CAPLIN
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 203521 EMCURE PHARMS LTD
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 091596 FRESENIUS KABI USA
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 207239 GLAND PHARMA LTD
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 201885 LUITPOLD
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 206713 MICRO LABS
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 091657 MYLAN INSTITUTIONAL
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 202755 VIRTUS PHARMS
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 201580 X-GEN PHARMS INC
TRANEXAMIC ACID TRANEXAMIC ACID 100MG/ML INJECTABLE;INJECTION Prescription No AP 205228 ZYDUS PHARMS

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