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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203553

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MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
EQ 45MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOCYCLINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 45MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A203553
Product Number: 001
Approval Date: Nov 16, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
EQ 55MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOCYCLINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 55MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A203553
Product Number: 002
Approval Date: Jun 16, 2023
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
EQ 65MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOCYCLINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 65MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A203553
Product Number: 003
Approval Date: Jun 16, 2023
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
EQ 80MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOCYCLINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 80MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A203553
Product Number: 004
Approval Date: Nov 16, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
EQ 90MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOCYCLINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 90MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A203553
Product Number: 005
Approval Date: Nov 16, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
EQ 105MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOCYCLINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 105MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A203553
Product Number: 006
Approval Date: Nov 16, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
EQ 115MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOCYCLINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 115MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A203553
Product Number: 007
Approval Date: Jun 16, 2023
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
EQ 135MG BASE
Marketing Status: Discontinued
Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOCYCLINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 135MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A203553
Product Number: 008
Approval Date: Nov 16, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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