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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075731
Company: TARO

Products on ANDA 075731

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075731

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
10/17/2024	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/17/2024	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/17/2024	SUPPL-9	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 075731

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; 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

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

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