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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091038
Company: SUN PHARM INDS
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
06/17/2021 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/19/2015 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/19/2015 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/19/2015 SUPPL-2 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 203333 CHARTWELL MOLECULAR
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 076255 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 206155 INDOCO
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 202862 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Prescription No AB 202287 ORBION PHARMS
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 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 203333 CHARTWELL MOLECULAR
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 076255 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 206155 INDOCO
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 202862 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Prescription No AB 202287 ORBION PHARMS
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 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 203333 CHARTWELL MOLECULAR
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 076255 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 206155 INDOCO
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 202862 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Prescription No AB 202287 ORBION PHARMS
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 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 203333 CHARTWELL MOLECULAR
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 076255 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 206155 INDOCO
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 202862 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Prescription No AB 202287 ORBION PHARMS
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 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 203333 CHARTWELL MOLECULAR
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 076133 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 206155 INDOCO
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 202862 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Prescription No AB 202287 ORBION PHARMS
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 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 203333 CHARTWELL MOLECULAR
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 076133 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 206155 INDOCO
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 202862 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL Prescription No AB 202287 ORBION PHARMS
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 090459 ZYDUS PHARMS
ZYPREXA OLANZAPINE 20MG TABLET;ORAL Prescription Yes AB 020592 LILLY
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