Details for New Drug Application (NDA): 022370

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NDA 022370 describes CONZIP, which is a drug marketed by Cipher Pharms Inc and is included in one NDA. It is available from four suppliers. Additional details are available on the CONZIP profile page.

The generic ingredient in CONZIP is tramadol hydrochloride. There are thirty-six drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

Summary for 022370

Tradename:	CONZIP
Applicant:	Cipher Pharms Inc
Ingredient:	tramadol hydrochloride
Patents:	0

Pharmacology for NDA: 022370

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 022370

Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 022370

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CONZIP	tramadol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022370	NDA AUTHORIZED GENERIC	Trigen Laboratories, LLC	13811-689	13811-689-30	30 CAPSULE in 1 BOTTLE, PLASTIC (13811-689-30)
CONZIP	tramadol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022370	NDA AUTHORIZED GENERIC	Trigen Laboratories, LLC	13811-690	13811-690-30	30 CAPSULE in 1 BOTTLE, PLASTIC (13811-690-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	May 7, 2010	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	200MG
Approval Date:	May 7, 2010	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	300MG
Approval Date:	May 7, 2010	TE:		RLD:	Yes

Expired US Patents for NDA 022370

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cipher Pharms Inc	CONZIP	tramadol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022370-001	May 7, 2010	⤷ Sign Up	⤷ Sign Up
Cipher Pharms Inc	CONZIP	tramadol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022370-003	May 7, 2010	⤷ Sign Up	⤷ Sign Up
Cipher Pharms Inc	CONZIP	tramadol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	022370-002	May 7, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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