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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211033
Company: ALEMBIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLONAZEPAM CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CLONAZEPAM CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CLONAZEPAM CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CLONAZEPAM CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
CLONAZEPAM CLONAZEPAM 2MG 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
06/28/2019 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
01/17/2023 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/05/2021 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

CLONAZEPAM

TABLET, ORALLY DISINTEGRATING;ORAL; 0.125MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 211033 ALEMBIC
CLONAZEPAM CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077194 BARR
CLONAZEPAM CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077171 ENDO OPERATIONS
CLONAZEPAM CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078654 SUN PHARM INDS INC

TABLET, ORALLY DISINTEGRATING;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 211033 ALEMBIC
CLONAZEPAM CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077194 BARR
CLONAZEPAM CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077171 ENDO OPERATIONS
CLONAZEPAM CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078654 SUN PHARM INDS INC

TABLET, ORALLY DISINTEGRATING;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 211033 ALEMBIC
CLONAZEPAM CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077194 BARR
CLONAZEPAM CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077171 ENDO OPERATIONS
CLONAZEPAM CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078654 SUN PHARM INDS INC

TABLET, ORALLY DISINTEGRATING;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 211033 ALEMBIC
CLONAZEPAM CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077194 BARR
CLONAZEPAM CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077171 ENDO OPERATIONS
CLONAZEPAM CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078654 SUN PHARM INDS INC

TABLET, ORALLY DISINTEGRATING;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 211033 ALEMBIC
CLONAZEPAM CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077194 BARR
CLONAZEPAM CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077171 ENDO OPERATIONS
CLONAZEPAM CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 078654 SUN PHARM INDS INC
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