Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076534
Company: DR REDDYS LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;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
10/24/2011 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/076534s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/12/2014 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

12/12/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

03/18/2013 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

OLANZAPINE

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 091265 APOTEX INC
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203708 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077243 BARR LABS INC
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076534 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203456 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200221 JUBILANT GENERICS
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203044 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202285 MYLAN
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202937 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078109 PAR PHARM
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090881 SUN PHARM INDS
OLANZAPINE OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 091415 TORRENT PHARMS LLC
ZYPREXA ZYDIS OLANZAPINE 5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021086 LILLY

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 091265 APOTEX INC
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203708 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077243 BARR LABS INC
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076534 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203456 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200221 JUBILANT GENERICS
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203044 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202285 MYLAN
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202937 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078109 PAR PHARM
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090881 SUN PHARM INDS
OLANZAPINE OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 091415 TORRENT PHARMS LLC
ZYPREXA ZYDIS OLANZAPINE 10MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021086 LILLY

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 091265 APOTEX INC
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203708 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077243 BARR LABS INC
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076534 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203456 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200221 JUBILANT GENERICS
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203044 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202285 MYLAN
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202937 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078109 PAR PHARM
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090881 SUN PHARM INDS
OLANZAPINE OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 091415 TORRENT PHARMS LLC
ZYPREXA ZYDIS OLANZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021086 LILLY

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 091265 APOTEX INC
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203708 AUROBINDO PHARMA LTD
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077243 BARR LABS INC
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 076534 DR REDDYS LABS LTD
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203456 INVAGEN PHARMS
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 200221 JUBILANT GENERICS
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203044 MACLEODS PHARMS LTD
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202285 MYLAN
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 202937 ORCHID HLTHCARE
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078109 PAR PHARM
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090881 SUN PHARM INDS
OLANZAPINE OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 091415 TORRENT PHARMS LLC
ZYPREXA ZYDIS OLANZAPINE 20MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021086 LILLY

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