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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210546
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;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
12/28/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/03/2021 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

CLOBAZAM

SUSPENSION;ORAL; 2.5MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 216008 ACCORD HLTHCARE
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 213039 ALKEM LABS LTD
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 210039 AMNEAL
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 214404 AUROBINDO PHARMA LTD
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 208819 BIONPHARMA INC
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 213110 CHARTWELL MOLECULAR
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 209796 HETERO LABS LTD III
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 209715 HIKMA
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 210546 LUPIN LTD
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 211259 MYLAN
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 210978 TARO
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 210569 UPSHER SMITH LABS
CLOBAZAM CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription No AB 210746 VISTAPHARM
ONFI CLOBAZAM 2.5MG/ML SUSPENSION;ORAL Prescription Yes AB 203993 LUNDBECK PHARMS LLC
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