Details for New Drug Application (NDA): 017105

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NDA 017105 describes TRANXENE SD, which is a drug marketed by Ajenat Pharms and is included in one NDA. Additional details are available on the TRANXENE SD profile page.

The generic ingredient in TRANXENE SD is clorazepate dipotassium. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the clorazepate dipotassium profile page.

Summary for 017105

Tradename:	TRANXENE SD
Applicant:	Ajenat Pharms
Ingredient:	clorazepate dipotassium
Patents:	0

Medical Subject Heading (MeSH) Categories for 017105

Anti-Anxiety Agents
Anticonvulsants
GABA Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	3.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	7.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 017105

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ajenat Pharms	TRANXENE	clorazepate dipotassium	CAPSULE;ORAL	017105-001	Approved Prior to Jan 1, 1982	RE28315	⤷ Start Trial
Ajenat Pharms	TRANXENE	clorazepate dipotassium	TABLET;ORAL	017105-008	Approved Prior to Jan 1, 1982	RE28315	⤷ Start Trial
Ajenat Pharms	TRANXENE SD	clorazepate dipotassium	TABLET;ORAL	017105-004	Approved Prior to Jan 1, 1982	RE28315	⤷ Start Trial
Ajenat Pharms	TRANXENE	clorazepate dipotassium	CAPSULE;ORAL	017105-002	Approved Prior to Jan 1, 1982	RE28315	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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