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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 016798

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NDA 016798 describes SINEQUAN, which is a drug marketed by Pfizer and is included in two NDAs. Additional details are available on the SINEQUAN profile page.

The generic ingredient in SINEQUAN is doxepin hydrochloride. There are seven drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for 016798

Tradename:	SINEQUAN
Applicant:	Pfizer
Ingredient:	doxepin hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 016798

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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 016798

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-006	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-007	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-005	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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