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Last Updated: November 18, 2019

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Details for New Drug Application (NDA): 050808

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NDA 050808 describes SOLODYN, which is a drug marketed by Medicis and is included in one NDA. It is available from three suppliers. 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. Forty-eight suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 050808
Tradename:SOLODYN
Applicant:Medicis
Ingredient:minocycline hydrochloride
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 050808
Medical Subject Heading (MeSH) Categories for 050808
Suppliers and Packaging for NDA: 050808
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808 NDA AUTHORIZED GENERIC Amneal Pharmaceuticals of New York, LLC 0115-9935 0115-9935-08 1 BOTTLE in 1 CARTON (0115-9935-08) > 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808 NDA AUTHORIZED GENERIC Amneal Pharmaceuticals of New York, LLC 0115-9936 0115-9936-08 1 BOTTLE in 1 CARTON (0115-9936-08) > 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Paragraph IV (Patent) Challenges for 050808
Tradename Dosage Ingredient NDA Submissiondate
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2010-12-13
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2010-12-02
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2010-10-27
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2009-11-19

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 8, 2006TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:  Start TrialPatent Expiration:Mar 7, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:  Start TrialPatent Expiration:Jun 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE

Expired US Patents for NDA 050808

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-003 May 8, 2006   Start Trial   Start Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-001 May 8, 2006   Start Trial   Start Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-002 May 8, 2006   Start Trial   Start Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009   Start Trial   Start Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-008 Aug 27, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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