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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 fourteen suppliers. There is one patent protecting this drug. 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. Sixty-nine suppliers are listed for this compound. Additional details are available on the tramadol hydrochloride profile page.

Summary for NDA: 022370

Tradename:
CONZIP
Applicant:
Cipher Pharms Inc
Ingredient:
tramadol hydrochloride
Patents:1
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 022370

Mechanism of ActionFull Opioid Agonists

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:May 7, 2010TE:RLD:Yes
Patent:7,858,118Patent Expiration:Apr 11, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF TRAMADOL FOR THE MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength200MG
Approval Date:May 7, 2010TE:RLD:No
Patent:7,858,118Patent Expiration:Apr 11, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF TRAMADOL FOR THE MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength300MG
Approval Date:May 7, 2010TE:RLD:No
Patent:7,858,118Patent Expiration:Apr 11, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF TRAMADOL FOR THE MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN


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