U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040616
Company: PLIVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
WARFARIN SODIUM WARFARIN SODIUM 2MG TABLET;ORAL Prescription AB No No
WARFARIN SODIUM WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription AB No No
WARFARIN SODIUM WARFARIN SODIUM 3MG TABLET;ORAL Prescription AB No No
WARFARIN SODIUM WARFARIN SODIUM 4MG TABLET;ORAL Prescription AB No No
WARFARIN SODIUM WARFARIN SODIUM 5MG TABLET;ORAL Prescription AB No No
WARFARIN SODIUM WARFARIN SODIUM 6MG TABLET;ORAL Prescription AB No No
WARFARIN SODIUM WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription AB No No
WARFARIN SODIUM WARFARIN SODIUM 10MG TABLET;ORAL Prescription AB No Yes
WARFARIN SODIUM WARFARIN SODIUM 1MG 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
07/05/2006 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
09/05/2018 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

09/05/2018 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/05/2018 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/05/2018 SUPPL-12 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/05/2018 SUPPL-9 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

07/11/2007 SUPPL-2 Labeling

Label is not available on this site.

WARFARIN SODIUM

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
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 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
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
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 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
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
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 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
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
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 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
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
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 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
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
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 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
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
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 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
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
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 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
WARFARIN SODIUM WARFARIN SODIUM 10MG 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
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 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
WARFARIN SODIUM WARFARIN SODIUM 1MG TABLET;ORAL Prescription No AB 040663 ZYDUS PHARMS USA
Back to Top