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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215939
Company: ANNORA PHARMA
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
01/11/2022 ORIG-1 Approval STANDARD

Label is not available on this site.

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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