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-two 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

Pharmacology for NDA: 050781

Physiological Effect	Decreased Prothrombin Activity

Medical Subject Heading (MeSH) Categories for 050781

Anti-Bacterial Agents

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:	RX	Dosage:	POWDER, EXTENDED RELEASE;DENTAL			Strength	EQ 1MG BASE
Approval Date:	Feb 16, 2001	TE:		RLD:	Yes

Expired US Patents for NDA 050781

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

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