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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077802
Company: GLENMARK PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription AB No No
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription AB No No
OXCARBAZEPINE OXCARBAZEPINE 600MG 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
10/09/2007 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077802s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/25/2020 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

08/25/2020 SUPPL-15 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

08/25/2020 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

01/20/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/19/2012 SUPPL-5 REMS-Modified

Label is not available on this site.

12/28/2011 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.

06/29/2010 SUPPL-2 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
10/09/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf

OXCARBAZEPINE

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 215939 ANNORA PHARMA
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 078069 BRECKENRIDGE PHARM
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 077802 GLENMARK PHARMS LTD
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 077747 RUBICON
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 077794 SUN PHARM INDS
OXCARBAZEPINE OXCARBAZEPINE 150MG TABLET;ORAL Prescription No AB 077801 TARO
TRILEPTAL OXCARBAZEPINE 150MG TABLET;ORAL Prescription Yes AB 021014 NOVARTIS

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 215939 ANNORA PHARMA
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 078069 BRECKENRIDGE PHARM
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 077802 GLENMARK PHARMS LTD
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 077747 RUBICON
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 077794 SUN PHARM INDS
OXCARBAZEPINE OXCARBAZEPINE 300MG TABLET;ORAL Prescription No AB 077801 TARO
TRILEPTAL OXCARBAZEPINE 300MG TABLET;ORAL Prescription Yes AB 021014 NOVARTIS

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 215939 ANNORA PHARMA
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 078069 BRECKENRIDGE PHARM
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 077802 GLENMARK PHARMS LTD
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 077747 RUBICON
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 077794 SUN PHARM INDS
OXCARBAZEPINE OXCARBAZEPINE 600MG TABLET;ORAL Prescription No AB 077801 TARO
TRILEPTAL OXCARBAZEPINE 600MG TABLET;ORAL Prescription Yes AB 021014 NOVARTIS
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