Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050649

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MINOCIN (MINOCYCLINE HYDROCHLORIDE)
EQ 50MG BASE
Marketing Status: Prescription

Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOCIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050649
Product Number: 001
Approval Date: May 31, 1990
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MINOCIN (MINOCYCLINE HYDROCHLORIDE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOCIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050649
Product Number: 002
Approval Date: May 31, 1990
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MINOCIN (MINOCYCLINE HYDROCHLORIDE)
EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: MINOCIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N050649
Product Number: 003
Approval Date: Feb 12, 2001
Applicant Holder Full Name: BAUSCH HEALTH US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information