Details for New Drug Application (NDA): 014713

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NDA 014713 describes ETRAFON-FORTE, which is a drug marketed by Schering and is included in one NDA. Additional details are available on the ETRAFON-FORTE profile page.

The generic ingredient in ETRAFON-FORTE is amitriptyline hydrochloride; perphenazine. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amitriptyline hydrochloride; perphenazine profile page.

Summary for 014713

Tradename:	ETRAFON-FORTE
Applicant:	Schering
Ingredient:	amitriptyline hydrochloride; perphenazine
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	No

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	No

Profile for product number 006

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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:	No

Expired US Patents for NDA 014713

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	ETRAFON 2-10	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014713-007	Approved Prior to Jan 1, 1982	⤷ Subscribe	⤷ Subscribe
Schering	ETRAFON-FORTE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014713-006	Approved Prior to Jan 1, 1982	⤷ Subscribe	⤷ Subscribe
Schering	ETRAFON 2-25	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014713-004	Approved Prior to Jan 1, 1982	⤷ Subscribe	⤷ Subscribe
Schering	ETRAFON-A	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014713-002	Approved Prior to Jan 1, 1982	⤷ Subscribe	⤷ Subscribe
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