Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075731
Company: TARO PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET;ORAL Prescription AB No No
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription AB No No
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG 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
04/27/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75731ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/20/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/27/2011 SUPPL-3 Labeling-Medication Guide, REMS-Proposal

Label is not available on this site.

01/20/2010 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

CLORAZEPATE DIPOTASSIUM

TABLET;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET;ORAL Prescription No AB 071858 MYLAN
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET;ORAL Prescription No AB 075731 TARO PHARM
GEN-XENE CLORAZEPATE DIPOTASSIUM 15MG TABLET;ORAL Prescription No AB 071789 ALRA

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription No AB 071858 MYLAN
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription No AB 075731 TARO PHARM
GEN-XENE CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription No AB 071788 ALRA
TRANXENE CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription Yes AB 017105 RECORDATI RARE

TABLET;ORAL; 3.75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG TABLET;ORAL Prescription No AB 071858 MYLAN
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG TABLET;ORAL Prescription No AB 075731 TARO PHARM
GEN-XENE CLORAZEPATE DIPOTASSIUM 3.75MG TABLET;ORAL Prescription No AB 071787 ALRA

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