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Details for New Drug Application (NDA): 204442

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NDA 204442 describes PROBUPHINE, which is a drug marketed by Braeburn Pharms 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 PROBUPHINE profile page.

The generic ingredient in PROBUPHINE is buprenorphine hydrochloride. There are twenty-eight drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.

Summary for NDA: 204442

Tradename:
PROBUPHINE
Applicant:
Braeburn Pharms Inc
Ingredient:
buprenorphine hydrochloride
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 204442

Mechanism of ActionPartial Opioid Agonists

Suppliers and Packaging for NDA: 204442

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROBUPHINE
buprenorphine hydrochloride
IMPLANT;IMPLANTATION 204442 NDA Braeburn Pharmaceuticals 58284-100 58284-100-14 4 POUCH in 1 CARTON (58284-100-14) > 1 IMPLANT in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;IMPLANTATIONStrengthEQ 80MG BASE/IMPLANT
Approval Date:May 26, 2016TE:RLD:Yes
Patent:7,736,665Patent Expiration:Apr 25, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:FOR OPIOID DEPENDENCE
Regulatory Exclusivity Expiration:May 26, 2019
Regulatory Exclusivity Use:NEW PRODUCT


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