Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078243
Company: ZYDUS PHARMS USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription AB No No
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription AB No No
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG 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
10/06/2010 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
06/10/2015 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

09/21/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

09/21/2014 SUPPL-14 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

03/19/2013 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/20/2012 SUPPL-9 Labeling-Container/Carton Labels

Label is not available on this site.

12/19/2012 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

01/03/2012 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

03/22/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

06/10/2015 SUPPL-3 Labeling

Label is not available on this site.

10/22/2010 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

LOSARTAN POTASSIUM

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COZAAR LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription Yes AB 020386 MERCK SHARP DOHME
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 090428 ALEMBIC PHARMS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 090790 APOTEX CORP
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 090083 AUROBINDO PHARMA
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 201170 CADISTA PHARMS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 203835 HETERO LABS LTD V
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 200290 IPCA LABS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 078232 LUPIN LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 202230 MACLEODS PHARMS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 091590 MYLAN
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 091497 PRINSTON INC
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 077424 SANDOZ
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 076958 TEVA
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 090467 TORRENT PHARMS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 203030 UNICHEM LABS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 090544 UPSHER-SMITH LABS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 091541 VIVA HLTHCARE
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 090382 VIVIMED GLOBAL
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 091129 WATSON LABS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 077459 WEST-WARD PHARMS INT
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 25MG TABLET;ORAL Prescription No AB 078243 ZYDUS PHARMS USA INC

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COZAAR LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription Yes AB 020386 MERCK SHARP DOHME
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 090428 ALEMBIC PHARMS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 090790 APOTEX CORP
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 090083 AUROBINDO PHARMA
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 201170 CADISTA PHARMS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 203835 HETERO LABS LTD V
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 200290 IPCA LABS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 078232 LUPIN LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 202230 MACLEODS PHARMS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 091590 MYLAN
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 091497 PRINSTON INC
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 077424 SANDOZ
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 076958 TEVA
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 090467 TORRENT PHARMS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 203030 UNICHEM LABS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 090544 UPSHER-SMITH LABS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 091541 VIVA HLTHCARE
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 090382 VIVIMED GLOBAL
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 091129 WATSON LABS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 077459 WEST-WARD PHARMS INT
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 50MG TABLET;ORAL Prescription No AB 078243 ZYDUS PHARMS USA INC

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COZAAR LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription Yes AB 020386 MERCK SHARP DOHME
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 090428 ALEMBIC PHARMS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 090790 APOTEX CORP
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 090083 AUROBINDO PHARMA
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 201170 CADISTA PHARMS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 203835 HETERO LABS LTD V
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 200290 IPCA LABS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 078232 LUPIN LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 202230 MACLEODS PHARMS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 091590 MYLAN
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 091497 PRINSTON INC
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 077424 SANDOZ
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 076958 TEVA
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 090467 TORRENT PHARMS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 203030 UNICHEM LABS LTD
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 090544 UPSHER-SMITH LABS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 091541 VIVA HLTHCARE
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 090382 VIVIMED GLOBAL
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 091129 WATSON LABS
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 077459 WEST-WARD PHARMS INT
LOSARTAN POTASSIUM LOSARTAN POTASSIUM 100MG TABLET;ORAL Prescription No AB 078243 ZYDUS PHARMS USA INC

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