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Generated: April 23, 2019

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Details for New Drug Application (NDA): 020616

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NDA 020616 describes KADIAN, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from three suppliers. Additional details are available on the KADIAN profile page.

The generic ingredient in KADIAN is morphine sulfate. There are twenty-three drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 020616
Tradename:KADIAN
Applicant:Allergan Sales Llc
Ingredient:morphine sulfate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020616
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 020616
Suppliers and Packaging for NDA: 020616
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616 NDA Allergan, Inc. 0023-6011 0023-6011-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0023-6011-60)
KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616 NDA Allergan, Inc. 0023-6012 0023-6012-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0023-6012-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jul 3, 1996TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength50MG
Approval Date:Jul 3, 1996TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Jul 3, 1996TE:ABRLD:Yes

Expired US Patents for NDA 020616

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-005 Mar 9, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-002 Jul 3, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-001 Jul 3, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Allergan Sales Llc KADIAN morphine sulfate CAPSULE, EXTENDED RELEASE;ORAL 020616-007 Feb 27, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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