Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091434
Company: TORRENT PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription AB No No
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription AB No No
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription AB No No
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription AB No No
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription AB No No
OLANZAPINE OLANZAPINE 20MG 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
04/23/2012 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
12/08/2014 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

OLANZAPINE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 202295 ALKEM LABS LTD
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 090798 APOTEX INC
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 202050 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 076255 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 204866 HIKMA PHARMS
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 203333 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 209399 JIANGSU HANSOH PHARM
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 202862 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 202287 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 204319 QILU
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 091038 SUN PHARM INDS
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 076000 TEVA PHARMS
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 091434 TORRENT PHARMS LTD
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 090459 ZYDUS PHARMS
ZYPREXA OLANZAPINE 2.5MG TABLET;ORAL Prescription Yes AB 020592 LILLY

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 202295 ALKEM LABS LTD
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 090798 APOTEX INC
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 202050 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 076255 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 204866 HIKMA PHARMS
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 203333 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 209399 JIANGSU HANSOH PHARM
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 202862 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 202287 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 204319 QILU
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 091038 SUN PHARM INDS
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 076000 TEVA PHARMS
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 091434 TORRENT PHARMS LTD
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 090459 ZYDUS PHARMS
ZYPREXA OLANZAPINE 5MG TABLET;ORAL Prescription Yes AB 020592 LILLY

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 202295 ALKEM LABS LTD
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 090798 APOTEX INC
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 202050 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 076255 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 204866 HIKMA PHARMS
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 203333 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 202862 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 202287 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 204319 QILU
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 091038 SUN PHARM INDS
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 076000 TEVA PHARMS
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 091434 TORRENT PHARMS LTD
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 090459 ZYDUS PHARMS
ZYPREXA OLANZAPINE 7.5MG TABLET;ORAL Prescription Yes AB 020592 LILLY

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 202295 ALKEM LABS LTD
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 090798 APOTEX INC
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 202050 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 076255 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 204866 HIKMA PHARMS
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 203333 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 209399 JIANGSU HANSOH PHARM
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 202862 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 202287 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 204319 QILU
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 091038 SUN PHARM INDS
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 076000 TEVA PHARMS
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 091434 TORRENT PHARMS LTD
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 090459 ZYDUS PHARMS
ZYPREXA OLANZAPINE 10MG TABLET;ORAL Prescription Yes AB 020592 LILLY

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 202295 ALKEM LABS LTD
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 090798 APOTEX INC
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 202050 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 076133 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 204866 HIKMA PHARMS
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 203333 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 202862 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 202287 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 204319 QILU
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 091038 SUN PHARM INDS
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 076000 TEVA PHARMS
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 091434 TORRENT PHARMS LTD
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 090459 ZYDUS PHARMS
ZYPREXA OLANZAPINE 15MG TABLET;ORAL Prescription Yes AB 020592 LILLY

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 202295 ALKEM LABS LTD
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 090798 APOTEX INC
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 202050 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 076133 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 204866 HIKMA PHARMS
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 203333 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 077301 IVAX PHARMS INC
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 202862 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 202287 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 204319 QILU
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 091038 SUN PHARM INDS
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 091434 TORRENT PHARMS LTD
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 090459 ZYDUS PHARMS
ZYPREXA OLANZAPINE 20MG TABLET;ORAL Prescription Yes AB 020592 LILLY

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