Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065131

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

Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOCYCLINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065131
Product Number: 001
Approval Date: Apr 16, 2003
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

MINOCYCLINE HYDROCHLORIDE (MINOCYCLINE HYDROCHLORIDE)
EQ 75MG BASE
Marketing Status: Prescription

Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOCYCLINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065131
Product Number: 002
Approval Date: Apr 16, 2003
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: MINOCYCLINE HYDROCHLORIDE
Proprietary Name: MINOCYCLINE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A065131
Product Number: 003
Approval Date: Apr 16, 2003
Applicant Holder Full Name: STRIDES PHARMA GLOBAL PTE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information