Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040416
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JANTOVEN WARFARIN SODIUM 1MG TABLET;ORAL Prescription AB No No
JANTOVEN WARFARIN SODIUM 2MG TABLET;ORAL Prescription AB No No
JANTOVEN WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription AB No No
JANTOVEN WARFARIN SODIUM 3MG TABLET;ORAL Prescription AB No No
JANTOVEN WARFARIN SODIUM 4MG TABLET;ORAL Prescription AB No No
JANTOVEN WARFARIN SODIUM 5MG TABLET;ORAL Prescription AB No No
JANTOVEN WARFARIN SODIUM 6MG TABLET;ORAL Prescription AB No No
JANTOVEN WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription AB No No
JANTOVEN WARFARIN SODIUM 10MG TABLET;ORAL Prescription AB No 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
10/02/2003 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/30/2015 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

03/27/2012 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

05/20/2010 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

03/28/2008 SUPPL-16 Labeling

Label is not available on this site.

07/11/2007 SUPPL-14 Labeling

Label is not available on this site.

01/12/2007 SUPPL-11 Labeling

Label is not available on this site.

05/05/2006 SUPPL-6 Labeling

Label is not available on this site.

11/29/2004 SUPPL-5 Labeling

Label is not available on this site.

JANTOVEN

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 UPSHER SMITH LABS
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; 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 UPSHER SMITH LABS
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; 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 UPSHER SMITH LABS
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; 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 UPSHER SMITH LABS
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; 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 UPSHER SMITH LABS
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; 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 UPSHER SMITH LABS
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; 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 UPSHER SMITH LABS
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

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 UPSHER SMITH LABS
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; 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 UPSHER SMITH LABS
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

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