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Details for New Drug Application (NDA): 021217

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NDA 021217 describes EXALGO, which is a drug marketed by Mallinckrodt Inc and is included in one NDA. It is available from five suppliers. Additional details are available on the EXALGO profile page.

The generic ingredient in EXALGO is hydromorphone hydrochloride. There are thirteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for NDA: 021217

Tradename:
EXALGO
Applicant:
Mallinckrodt Inc
Ingredient:
hydromorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 021217

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 021217

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021217 NDA AUTHORIZED GENERIC Mallinckrodt, Inc. 0406-3308 0406-3308-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-3308-01)
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 021217 NDA AUTHORIZED GENERIC Mallinckrodt, Inc. 0406-3312 0406-3312-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-3312-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength8MG
Approval Date:Mar 1, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength12MG
Approval Date:Mar 1, 2010TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength16MG
Approval Date:Mar 1, 2010TE:ABRLD:No

Expired Orange Book Patents for NDA: 021217

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-001Mar 1, 20105,702,725► subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-003Mar 1, 20105,702,725► subscribe
Mallinckrodt Inc
EXALGO
hydromorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL021217-004Aug 24, 20125,702,725► subscribe
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