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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216988
Company: RUBICON RESEARCH

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
05/21/2026 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216988Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216988Orig1s000ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/21/2026 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216988Orig1s000lbl.pdf

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 PH HEALTH
CLONAZEPAM CLONAZEPAM 0.125MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 216988 RUBICON RESEARCH

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 PH HEALTH
CLONAZEPAM CLONAZEPAM 0.25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 216988 RUBICON RESEARCH

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 PH HEALTH
CLONAZEPAM CLONAZEPAM 0.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 216988 RUBICON RESEARCH

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 PH HEALTH
CLONAZEPAM CLONAZEPAM 1MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 216988 RUBICON RESEARCH

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 PH HEALTH
CLONAZEPAM CLONAZEPAM 2MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 216988 RUBICON RESEARCH
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