Details for New Drug Application (NDA): 050808

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NDA 050808 describes SOLODYN, which is a drug marketed by Bausch and is included in one NDA. There are eight patents protecting this drug and four Paragraph IV challenges. Additional details are available on the SOLODYN profile page.

The generic ingredient in SOLODYN 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 050808

Tradename:	SOLODYN
Applicant:	Bausch
Ingredient:	minocycline hydrochloride
Patents:	8

Medical Subject Heading (MeSH) Categories for 050808

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 8, 2006	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jun 24, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACNE
Patent:	⤷ Sign Up	Patent Expiration:	Mar 7, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACNE
Patent:	⤷ Sign Up	Patent Expiration:	Jun 24, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACNE

Expired US Patents for NDA 050808

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-004	Jul 23, 2009	⤷ Sign Up	⤷ Sign Up
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-006	Aug 27, 2010	⤷ Sign Up	⤷ Sign Up
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-002	May 8, 2006	⤷ Sign Up	⤷ Sign Up
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-001	May 8, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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