Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077492
Company: OHM LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription AB No No
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription AB No No
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription AB No No
VALSARTAN VALSARTAN 320MG 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
06/26/2014 ORIG-1 Approval Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077492Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077492Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077492Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/20/2019 SUPPL-12 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

08/20/2019 SUPPL-11 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

08/20/2019 SUPPL-6 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

12/17/2015 SUPPL-3 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

12/17/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/26/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077492Orig1s000lbl.pdf

VALSARTAN

TABLET;ORAL; 40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN VALSARTAN 40MG TABLET;ORAL Prescription Yes AB 021283 NOVARTIS
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 091367 ALEMBIC PHARMS LTD
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 205536 ALKEM LABS LTD
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 204011 AMNEAL PHARMS
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 202223 AUROBINDO PHARMA LTD
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 203311 HETERO LABS LTD V
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 077530 IVAX PHARMS
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 203536 JUBILANT GENERICS
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 201677 LUPIN LTD
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 202696 MACLEODS PHARMS LTD
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 090866 MYLAN
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 077492 OHM LABS INC
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 204821 PRINSTON INC
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 205347 SQUARE PHARMS LTD
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 202728 TORRENT
VALSARTAN VALSARTAN 40MG TABLET;ORAL Prescription No AB 209261 UNICHEM LABS LTD

TABLET;ORAL; 80MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN VALSARTAN 80MG TABLET;ORAL Prescription Yes AB 021283 NOVARTIS
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 091367 ALEMBIC PHARMS LTD
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 205536 ALKEM LABS LTD
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 204011 AMNEAL PHARMS
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 202223 AUROBINDO PHARMA LTD
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 203311 HETERO LABS LTD V
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 077530 IVAX PHARMS
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 203536 JUBILANT GENERICS
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 201677 LUPIN LTD
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 202696 MACLEODS PHARMS LTD
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 090866 MYLAN
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 077492 OHM LABS INC
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 204821 PRINSTON INC
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 205347 SQUARE PHARMS LTD
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 202728 TORRENT
VALSARTAN VALSARTAN 80MG TABLET;ORAL Prescription No AB 209261 UNICHEM LABS LTD

TABLET;ORAL; 160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN VALSARTAN 160MG TABLET;ORAL Prescription Yes AB 021283 NOVARTIS
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 091367 ALEMBIC PHARMS LTD
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 205536 ALKEM LABS LTD
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 204011 AMNEAL PHARMS
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 202223 AUROBINDO PHARMA LTD
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 203311 HETERO LABS LTD V
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 077530 IVAX PHARMS
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 203536 JUBILANT GENERICS
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 201677 LUPIN LTD
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 202696 MACLEODS PHARMS LTD
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 090866 MYLAN
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 077492 OHM LABS INC
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 204821 PRINSTON INC
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 205347 SQUARE PHARMS LTD
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 202728 TORRENT
VALSARTAN VALSARTAN 160MG TABLET;ORAL Prescription No AB 209261 UNICHEM LABS LTD

TABLET;ORAL; 320MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIOVAN VALSARTAN 320MG TABLET;ORAL Prescription Yes AB 021283 NOVARTIS
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 091367 ALEMBIC PHARMS LTD
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 205536 ALKEM LABS LTD
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 204011 AMNEAL PHARMS
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 202223 AUROBINDO PHARMA LTD
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 203311 HETERO LABS LTD V
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 077530 IVAX PHARMS
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 203536 JUBILANT GENERICS
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 201677 LUPIN LTD
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 202696 MACLEODS PHARMS LTD
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 090866 MYLAN
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 077492 OHM LABS INC
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 204821 PRINSTON INC
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 205347 SQUARE PHARMS LTD
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 202728 TORRENT
VALSARTAN VALSARTAN 320MG TABLET;ORAL Prescription No AB 209261 UNICHEM LABS LTD

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