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Last Updated: March 28, 2024

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. Additional details are available on the ARESTIN profile page.

The generic ingredient in ARESTIN is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 050781
Tradename:ARESTIN
Applicant:Orapharma
Ingredient:minocycline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 050781
Medical Subject Heading (MeSH) Categories for 050781
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER, EXTENDED RELEASE;DENTALStrengthEQ 1MG BASE
Approval Date:Feb 16, 2001TE:RLD:Yes

Expired US Patents for NDA 050781

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orapharma ARESTIN minocycline hydrochloride POWDER, EXTENDED RELEASE;DENTAL 050781-001 Feb 16, 2001 ⤷  Try a Trial ⤷  Try a Trial
Orapharma ARESTIN minocycline hydrochloride POWDER, EXTENDED RELEASE;DENTAL 050781-001 Feb 16, 2001 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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