Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009218
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COUMADIN WARFARIN SODIUM 10MG TABLET;ORAL Prescription AB Yes Yes
COUMADIN WARFARIN SODIUM 5MG TABLET;ORAL Prescription AB Yes No
COUMADIN WARFARIN SODIUM 75MG/VIAL INJECTABLE;INJECTION Discontinued None No No
COUMADIN WARFARIN SODIUM 2MG TABLET;ORAL Prescription AB Yes No
COUMADIN WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription AB Yes No
COUMADIN WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription AB Yes No
COUMADIN WARFARIN SODIUM 50MG/VIAL INJECTABLE;INJECTION Discontinued None No No
COUMADIN WARFARIN SODIUM 1MG TABLET;ORAL Prescription AB Yes No
COUMADIN WARFARIN SODIUM 4MG TABLET;ORAL Prescription AB Yes No
COUMADIN WARFARIN SODIUM 5MG/VIAL INJECTABLE;INJECTION Discontinued None No No
COUMADIN WARFARIN SODIUM 3MG TABLET;ORAL Prescription AB Yes No
COUMADIN WARFARIN SODIUM 6MG TABLET;ORAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/08/1954 ORIG-1 Approval Type 1 - New Molecular Entity 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
08/14/2017 SUPPL-118 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009218Orig1s118ltr.pdf
05/22/2017 SUPPL-117 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s017lbl.pdf
09/08/2016 SUPPL-116 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009218s116lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/009218Orig1s116ltr.pdf
10/28/2015 SUPPL-115 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009218Orig1s115ltr.pdf
12/02/2014 SUPPL-114 Manufacturing (CMC)

Label is not available on this site.

03/25/2013 SUPPL-113 Manufacturing (CMC)

Label is not available on this site.

01/22/2010 SUPPL-108 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009218s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009218s108ltr.pdf
10/04/2011 SUPPL-107 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009218s107ltr.pdf
08/16/2007 SUPPL-105 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009218s105lblv2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009218s105ltr.pdf
10/04/2006 SUPPL-102 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/009218s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/009218s102LTR.pdf
09/02/2005 SUPPL-101 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/009218s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/009218s101ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/009218_s101_coumadin.pdf
05/03/2002 SUPPL-99 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09218s099ltr.pdf
05/03/2002 SUPPL-98 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09218s098ltr.pdf
02/17/2000 SUPPL-97 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/09218S097_Coumadin.pdf
07/09/1999 SUPPL-96 Labeling

Label is not available on this site.

12/02/1999 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

03/31/1999 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

12/23/1998 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

06/01/1998 SUPPL-91 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf
06/01/1998 SUPPL-90 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf
04/16/1998 SUPPL-89 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/29/1997 SUPPL-88 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1998 SUPPL-87 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/01/1998 SUPPL-86 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf
09/05/1996 SUPPL-85 Labeling

Label is not available on this site.

11/08/1996 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

11/18/1996 SUPPL-83 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/07/1995 SUPPL-80 Labeling

Label is not available on this site.

03/08/1995 SUPPL-79 Manufacturing (CMC)-Control

Label is not available on this site.

02/07/1995 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

02/07/1995 SUPPL-77 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/28/1995 SUPPL-76 Efficacy-New Indication

Label is not available on this site.

08/06/1993 SUPPL-75 Labeling

Label is not available on this site.

03/31/1994 SUPPL-74 Efficacy-New Indication

Label is not available on this site.

06/08/1993 SUPPL-73 Labeling

Label is not available on this site.

02/01/1993 SUPPL-72 Labeling

Label is not available on this site.

08/20/1992 SUPPL-71 Labeling

Label is not available on this site.

08/24/1993 SUPPL-70 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/15/1993 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

04/11/1991 SUPPL-68 Labeling

Label is not available on this site.

04/11/1991 SUPPL-67 Labeling

Label is not available on this site.

05/10/1991 SUPPL-66 Manufacturing (CMC)

Label is not available on this site.

04/25/1990 SUPPL-65 Labeling

Label is not available on this site.

03/01/1990 SUPPL-64 Labeling

Label is not available on this site.

03/01/1990 SUPPL-63 Labeling

Label is not available on this site.

03/01/1990 SUPPL-62 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/01/1988 SUPPL-61 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/06/1987 SUPPL-60 Labeling

Label is not available on this site.

07/08/1986 SUPPL-59 Labeling

Label is not available on this site.

05/13/1985 SUPPL-56 Labeling

Label is not available on this site.

02/25/1985 SUPPL-54 Labeling

Label is not available on this site.

01/17/1985 SUPPL-52 Labeling

Label is not available on this site.

07/06/1987 SUPPL-51 Labeling

Label is not available on this site.

12/29/1980 SUPPL-42 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/01/1980 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1980 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/06/1979 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/14/1978 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1977 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1977 SUPPL-33 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/27/1976 SUPPL-32 Labeling

Label is not available on this site.

08/21/1975 SUPPL-31 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/14/2017 SUPPL-118 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf
08/14/2017 SUPPL-118 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf
05/22/2017 SUPPL-117 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s017lbl.pdf
05/22/2017 SUPPL-117 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s017lbl.pdf
09/08/2016 SUPPL-116 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009218s116lbl.pdf
10/28/2015 SUPPL-115 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf
10/28/2015 SUPPL-115 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf
10/04/2011 SUPPL-107 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf
01/22/2010 SUPPL-108 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009218s108lbl.pdf
08/16/2007 SUPPL-105 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009218s105lblv2.pdf
10/04/2006 SUPPL-102 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/009218s102lbl.pdf
09/02/2005 SUPPL-101 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/009218s101lbl.pdf

COUMADIN

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COUMADIN WARFARIN SODIUM 10MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 10MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
WARFARIN SODIUM WARFARIN SODIUM 10MG TABLET;ORAL Prescription No AB 202202 AMNEAL PHARMS
WARFARIN SODIUM WARFARIN SODIUM 10MG TABLET;ORAL Prescription No AB 040145 BARR
WARFARIN SODIUM WARFARIN SODIUM 10MG TABLET;ORAL Prescription No AB 090935 INVAGEN PHARMS
WARFARIN SODIUM WARFARIN SODIUM 10MG TABLET;ORAL Prescription No AB 200104 IPCA LABS LTD
WARFARIN SODIUM WARFARIN SODIUM 10MG TABLET;ORAL Prescription No AB 040616 PLIVA
WARFARIN SODIUM WARFARIN SODIUM 10MG TABLET;ORAL Prescription No AB 040301 TARO PHARM
WARFARIN SODIUM WARFARIN SODIUM 10MG TABLET;ORAL Prescription No AB 040663 ZYDUS PHARMS USA

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COUMADIN WARFARIN SODIUM 5MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 5MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
WARFARIN SODIUM WARFARIN SODIUM 5MG TABLET;ORAL Prescription No AB 202202 AMNEAL PHARMS
WARFARIN SODIUM WARFARIN SODIUM 5MG TABLET;ORAL Prescription No AB 040145 BARR
WARFARIN SODIUM WARFARIN SODIUM 5MG TABLET;ORAL Prescription No AB 090935 INVAGEN PHARMS
WARFARIN SODIUM WARFARIN SODIUM 5MG TABLET;ORAL Prescription No AB 200104 IPCA LABS LTD
WARFARIN SODIUM WARFARIN SODIUM 5MG TABLET;ORAL Prescription No AB 040616 PLIVA
WARFARIN SODIUM WARFARIN SODIUM 5MG TABLET;ORAL Prescription No AB 040301 TARO PHARM
WARFARIN SODIUM WARFARIN SODIUM 5MG TABLET;ORAL Prescription No AB 040663 ZYDUS PHARMS USA

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COUMADIN WARFARIN SODIUM 2MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 2MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
WARFARIN SODIUM WARFARIN SODIUM 2MG TABLET;ORAL Prescription No AB 202202 AMNEAL PHARMS
WARFARIN SODIUM WARFARIN SODIUM 2MG TABLET;ORAL Prescription No AB 040145 BARR
WARFARIN SODIUM WARFARIN SODIUM 2MG TABLET;ORAL Prescription No AB 090935 INVAGEN PHARMS
WARFARIN SODIUM WARFARIN SODIUM 2MG TABLET;ORAL Prescription No AB 200104 IPCA LABS LTD
WARFARIN SODIUM WARFARIN SODIUM 2MG TABLET;ORAL Prescription No AB 040616 PLIVA
WARFARIN SODIUM WARFARIN SODIUM 2MG TABLET;ORAL Prescription No AB 040301 TARO PHARM
WARFARIN SODIUM WARFARIN SODIUM 2MG TABLET;ORAL Prescription No AB 040663 ZYDUS PHARMS USA

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COUMADIN WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
WARFARIN SODIUM WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription No AB 202202 AMNEAL PHARMS
WARFARIN SODIUM WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription No AB 040145 BARR
WARFARIN SODIUM WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription No AB 090935 INVAGEN PHARMS
WARFARIN SODIUM WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription No AB 200104 IPCA LABS LTD
WARFARIN SODIUM WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription No AB 040616 PLIVA
WARFARIN SODIUM WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription No AB 040301 TARO PHARM
WARFARIN SODIUM WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription No AB 040663 ZYDUS PHARMS USA

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COUMADIN WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
WARFARIN SODIUM WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription No AB 202202 AMNEAL PHARMS
WARFARIN SODIUM WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription No AB 040145 BARR
WARFARIN SODIUM WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription No AB 090935 INVAGEN PHARMS
WARFARIN SODIUM WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription No AB 200104 IPCA LABS LTD
WARFARIN SODIUM WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription No AB 040616 PLIVA
WARFARIN SODIUM WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription No AB 040301 TARO PHARM
WARFARIN SODIUM WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription No AB 040663 ZYDUS PHARMS USA

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COUMADIN WARFARIN SODIUM 1MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 1MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
WARFARIN SODIUM WARFARIN SODIUM 1MG TABLET;ORAL Prescription No AB 202202 AMNEAL PHARMS
WARFARIN SODIUM WARFARIN SODIUM 1MG TABLET;ORAL Prescription No AB 040145 BARR
WARFARIN SODIUM WARFARIN SODIUM 1MG TABLET;ORAL Prescription No AB 090935 INVAGEN PHARMS
WARFARIN SODIUM WARFARIN SODIUM 1MG TABLET;ORAL Prescription No AB 200104 IPCA LABS LTD
WARFARIN SODIUM WARFARIN SODIUM 1MG TABLET;ORAL Prescription No AB 040616 PLIVA
WARFARIN SODIUM WARFARIN SODIUM 1MG TABLET;ORAL Prescription No AB 040301 TARO PHARM
WARFARIN SODIUM WARFARIN SODIUM 1MG TABLET;ORAL Prescription No AB 040663 ZYDUS PHARMS USA

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COUMADIN WARFARIN SODIUM 4MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 4MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
WARFARIN SODIUM WARFARIN SODIUM 4MG TABLET;ORAL Prescription No AB 202202 AMNEAL PHARMS
WARFARIN SODIUM WARFARIN SODIUM 4MG TABLET;ORAL Prescription No AB 040145 BARR
WARFARIN SODIUM WARFARIN SODIUM 4MG TABLET;ORAL Prescription No AB 090935 INVAGEN PHARMS
WARFARIN SODIUM WARFARIN SODIUM 4MG TABLET;ORAL Prescription No AB 200104 IPCA LABS LTD
WARFARIN SODIUM WARFARIN SODIUM 4MG TABLET;ORAL Prescription No AB 040616 PLIVA
WARFARIN SODIUM WARFARIN SODIUM 4MG TABLET;ORAL Prescription No AB 040301 TARO PHARM
WARFARIN SODIUM WARFARIN SODIUM 4MG TABLET;ORAL Prescription No AB 040663 ZYDUS PHARMS USA

TABLET;ORAL; 3MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COUMADIN WARFARIN SODIUM 3MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 3MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
WARFARIN SODIUM WARFARIN SODIUM 3MG TABLET;ORAL Prescription No AB 202202 AMNEAL PHARMS
WARFARIN SODIUM WARFARIN SODIUM 3MG TABLET;ORAL Prescription No AB 040145 BARR
WARFARIN SODIUM WARFARIN SODIUM 3MG TABLET;ORAL Prescription No AB 090935 INVAGEN PHARMS
WARFARIN SODIUM WARFARIN SODIUM 3MG TABLET;ORAL Prescription No AB 200104 IPCA LABS LTD
WARFARIN SODIUM WARFARIN SODIUM 3MG TABLET;ORAL Prescription No AB 040616 PLIVA
WARFARIN SODIUM WARFARIN SODIUM 3MG TABLET;ORAL Prescription No AB 040301 TARO PHARM
WARFARIN SODIUM WARFARIN SODIUM 3MG TABLET;ORAL Prescription No AB 040663 ZYDUS PHARMS USA

TABLET;ORAL; 6MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COUMADIN WARFARIN SODIUM 6MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 6MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
WARFARIN SODIUM WARFARIN SODIUM 6MG TABLET;ORAL Prescription No AB 202202 AMNEAL PHARMS
WARFARIN SODIUM WARFARIN SODIUM 6MG TABLET;ORAL Prescription No AB 040145 BARR
WARFARIN SODIUM WARFARIN SODIUM 6MG TABLET;ORAL Prescription No AB 090935 INVAGEN PHARMS
WARFARIN SODIUM WARFARIN SODIUM 6MG TABLET;ORAL Prescription No AB 200104 IPCA LABS LTD
WARFARIN SODIUM WARFARIN SODIUM 6MG TABLET;ORAL Prescription No AB 040616 PLIVA
WARFARIN SODIUM WARFARIN SODIUM 6MG TABLET;ORAL Prescription No AB 040301 TARO PHARM
WARFARIN SODIUM WARFARIN SODIUM 6MG TABLET;ORAL Prescription No AB 040663 ZYDUS PHARMS USA

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