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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 nine 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-one suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

Summary for NDA: 020616

Tradename:
KADIAN
Applicant:
Allergan Sales Llc
Ingredient:
morphine sulfate
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 020616

Mechanism of ActionFull Opioid Agonists

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 AUTHORIZED GENERIC Actavis Elizabeth LLC 0228-3501 0228-3501-06 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3501-06)
KADIAN
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL 020616 NDA AUTHORIZED GENERIC Actavis Elizabeth LLC 0228-3501 0228-3501-11 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3501-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jul 3, 1996TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength50MG
Approval Date:Jul 3, 1996TE:ABRLD:No

Summary for product number 003

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

Expired Orange Book 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;ORAL020616-006Oct 27, 20065,202,128► subscribe
Allergan Sales Llc
KADIAN
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL020616-007Feb 27, 20075,202,128► subscribe
Allergan Sales Llc
KADIAN
morphine sulfate
CAPSULE, EXTENDED RELEASE;ORAL020616-008Apr 20, 20075,202,128► subscribe
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