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Details for New Drug Application (NDA): 050781

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NDA 050781 describes ARESTIN, which is a drug marketed by Orapharma and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ARESTIN profile page.

The generic ingredient in ARESTIN is minocycline hydrochloride. There are thirteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. There are fifteen tentative approvals for this compound. Additional details are available on the minocycline hydrochloride profile page.

Summary for NDA: 050781

Tradename:
ARESTIN
Applicant:
Orapharma
Ingredient:
minocycline hydrochloride
Patents:2
Therapeutic Class:Antibacterials
Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 050781

Ingredient-typeTetracyclines

Suppliers and Packaging for NDA: 050781

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARESTIN
minocycline hydrochloride
POWDER, EXTENDED RELEASE;DENTAL 050781 NDA OraPharma, Inc. 65976-100 65976-100-01 1 POWDER in 1 POUCH (65976-100-01)
ARESTIN
minocycline hydrochloride
POWDER, EXTENDED RELEASE;DENTAL 050781 NDA OraPharma, Inc. 65976-100 65976-100-12 1 POUCH in 1 BOX (65976-100-12) > 1 TRAY in 1 POUCH > 12 POWDER in 1 TRAY

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER, EXTENDED RELEASE;DENTALStrengthEQ 1MG BASE
Approval Date:Feb 16, 2001TE:RLD:Yes
Patent:6,682,348Patent Expiration:Mar 29, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:7,699,609Patent Expiration:Mar 29, 2022Product Flag?YSubstance Flag?Delist Request?


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