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Last Updated: November 2, 2024

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

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EXTENDED RELEASE;ORALStrengthEQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 8, 2006TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jun 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:⤷  Sign UpPatent Expiration:Mar 7, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:⤷  Sign UpPatent 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
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 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 050808-001 May 8, 2006 ⤷  Sign Up ⤷  Sign Up
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-007 Aug 27, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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