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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050808

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SOLODYN (MINOCYCLINE HYDROCHLORIDE)
EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: SOLODYN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050808
Product Number: 001
Approval Date: May 8, 2006
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SOLODYN (MINOCYCLINE HYDROCHLORIDE)
EQ 55MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: SOLODYN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 55MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050808
Product Number: 008
Approval Date: Aug 27, 2010
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SOLODYN (MINOCYCLINE HYDROCHLORIDE)
EQ 65MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: SOLODYN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 65MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050808
Product Number: 004
Approval Date: Jul 23, 2009
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SOLODYN (MINOCYCLINE HYDROCHLORIDE)
EQ 80MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: SOLODYN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 80MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050808
Product Number: 007
Approval Date: Aug 27, 2010
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SOLODYN (MINOCYCLINE HYDROCHLORIDE)
EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: SOLODYN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050808
Product Number: 002
Approval Date: May 8, 2006
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SOLODYN (MINOCYCLINE HYDROCHLORIDE)
EQ 105MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: SOLODYN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 105MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050808
Product Number: 006
Approval Date: Aug 27, 2010
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SOLODYN (MINOCYCLINE HYDROCHLORIDE)
EQ 115MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: SOLODYN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 115MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050808
Product Number: 005
Approval Date: Jul 23, 2009
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
SOLODYN (MINOCYCLINE HYDROCHLORIDE)
EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: SOLODYN
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050808
Product Number: 003
Approval Date: May 8, 2006
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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