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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213730
Company: NOVITIUM PHARMA

Products on ANDA 213730

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	3.75MG	TABLET;ORAL	Prescription	AB	No	No
CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	7.5MG	TABLET;ORAL	Prescription	AB	No	No
CLORAZEPATE DIPOTASSIUM	CLORAZEPATE DIPOTASSIUM	15MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213730

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2022	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
06/28/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213730

CLORAZEPATE DIPOTASSIUM

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

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

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