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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206544

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NDA 206544 describes MORPHABOND ER, which is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the MORPHABOND ER profile page.

The generic ingredient in MORPHABOND ER is morphine sulfate. There are twenty-three drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.

Summary for 206544

Tradename:1
Applicant:1
Ingredient:1
Patents:1
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 206544

Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories for 206544

Suppliers and Packaging for NDA: 206544

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544 NDA Daiichi Sankyo Inc. 65597-301 65597-301-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (65597-301-10)
MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544 NDA Daiichi Sankyo Inc. 65597-302 65597-302-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (65597-302-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Oct 2, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 2, 2018
Regulatory Exclusivity Use:
Patent:► SubscribePatent Expiration:Aug 12, 2028Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Oct 2, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 2, 2018
Regulatory Exclusivity Use:


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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