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Details for New Drug Application (NDA): 022321

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NDA 022321 describes EMBEDA, which is a drug marketed by Alpharma Pharms and is included in one NDA. It is available from two suppliers. There are nine patents protecting this drug and three Paragraph IV challenges. Additional details are available on the EMBEDA profile page.

The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.

Summary for NDA: 022321

Tradename:
EMBEDA
Applicant:
Alpharma Pharms
Ingredient:
morphine sulfate; naltrexone hydrochloride
Patents:9
Formulation / Manufacturing:see details

Pharmacology for NDA: 022321

Suppliers and Packaging for NDA: 022321

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 022321 NDA STAT RX USA LLC 16590-897 16590-897-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-897-30)
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 022321 NDA STAT RX USA LLC 16590-897 16590-897-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16590-897-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG;0.8MG
Approval Date:Aug 13, 2009TE:RLD:No
Patent:7,682,634Patent Expiration:Jun 19, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:7,815,934Patent Expiration:Dec 12, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,685,444Patent Expiration:Jul 3, 2025Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022321

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-001Aug 13, 20095,202,128► subscribe
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-003Aug 13, 20095,202,128► subscribe
Alpharma Pharms
EMBEDA
morphine sulfate; naltrexone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL022321-005Aug 13, 20095,202,128► subscribe
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