Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019281
Company: PFIZER
Company: PFIZER
| 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 |
|---|---|---|---|---|---|
| 08/29/2025 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019281s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/019281Orig1s048ltr.pdf | |
| 02/04/2021 | SUPPL-47 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019281Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019281Orig1s047ltr.pdf | |
| 06/07/2020 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019281s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019281Orig1s044ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 08/29/2025 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019281s048lbl.pdf | |
| 02/04/2021 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019281Orig1s047lbl.pdf | |
| 02/04/2021 | SUPPL-47 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019281Orig1s047lbl.pdf | |
| 06/07/2020 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019281s044lbl.pdf | |
| 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 | PFIZER |
| TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201885 | AM REGENT |
| 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 | 209860 | APOTEX |
| TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203521 | AVET LIFESCIENCES |
| TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 212360 | CAPLIN |
| TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202373 | EPIC PHARMA LLC |
| TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205035 | EUGIA PHARMA |
| TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 207239 | GLAND |
| TRANEXAMIC ACID | TRANEXAMIC ACID | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202436 | HERITAGE |
| 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 | 212676 | MILLA PHARMS |
| 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 | 201580 | XGEN PHARMS |