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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071858
Company: AUROBINDO PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET;ORAL Prescription AB No Yes
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG TABLET;ORAL Prescription AB No No
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG 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
07/17/1987 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/27/2010 SUPPL-20 Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Proposal

Label is not available on this site.
01/14/2010 SUPPL-19 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
12/02/2004 SUPPL-14 Labeling

Label is not available on this site.
12/01/2003 SUPPL-13 Labeling

Label is not available on this site.
02/25/1998 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
02/05/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
05/17/1993 SUPPL-8 Labeling

Label is not available on this site.
08/11/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
04/05/1991 SUPPL-6 Labeling

Label is not available on this site.
01/31/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
08/13/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
08/13/1987 SUPPL-1 Manufacturing (CMC)

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 AUROBINDO PHARMA
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET;ORAL Prescription No AB 215566 COREPHARMA
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET;ORAL Prescription No AB 213730 NOVITIUM PHARMA
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET;ORAL Prescription No AB 075731 TARO

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 AUROBINDO PHARMA
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG TABLET;ORAL Prescription No AB 215566 COREPHARMA
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG TABLET;ORAL Prescription No AB 213730 NOVITIUM PHARMA
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG TABLET;ORAL Prescription No AB 075731 TARO

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 AUROBINDO PHARMA
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription No AB 215566 COREPHARMA
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription No AB 213730 NOVITIUM PHARMA
CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription No AB 075731 TARO
TRANXENE CLORAZEPATE DIPOTASSIUM 7.5MG TABLET;ORAL Prescription Yes AB 017105 AJENAT PHARMS
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