Details for New Drug Application (NDA): 090462

NDA 090462 describes PROTRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Epic Pharma Llc, Hikma, and Sigmapharm Labs Llc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the PROTRIPTYLINE HYDROCHLORIDE profile page.

The generic ingredient in PROTRIPTYLINE HYDROCHLORIDE is protriptyline hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the protriptyline hydrochloride profile page.

Summary for 090462

Tradename:	PROTRIPTYLINE HYDROCHLORIDE
Applicant:	Sigmapharm Labs Llc
Ingredient:	protriptyline hydrochloride
Patents:	0

Pharmacology for NDA: 090462

Medical Subject Heading (MeSH) Categories for 090462

Adrenergic Uptake Inhibitors

Antidepressive Agents, Tricyclic

Suppliers and Packaging for NDA: 090462

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	090462	ANDA	Sigmapharm Laboratories, LLC	42794-004	42794-004-02	100 TABLET, FILM COATED in 1 BOTTLE (42794-004-02)
PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	090462	ANDA	Sigmapharm Laboratories, LLC	42794-007	42794-007-02	100 TABLET, FILM COATED in 1 BOTTLE (42794-007-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 3, 2010	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 3, 2010	TE:	AB	RLD:	No

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