Product Details for ANDA 213075
DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
EQ 75MG BASE
Marketing Status: Prescription
EQ 100MG BASE
Marketing Status: Prescription
EQ 150MG BASE
Marketing Status: Prescription
EQ 200MG BASE
Marketing Status: Prescription
EQ 75MG BASE
Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: DOXYCYCLINE HYCLATE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213075
Product Number: 001
Approval Date: Jan 3, 2022
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
Proprietary Name: DOXYCYCLINE HYCLATE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213075
Product Number: 001
Approval Date: Jan 3, 2022
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 100MG BASE
Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: DOXYCYCLINE HYCLATE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213075
Product Number: 002
Approval Date: Jan 3, 2022
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
Proprietary Name: DOXYCYCLINE HYCLATE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213075
Product Number: 002
Approval Date: Jan 3, 2022
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 150MG BASE
Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: DOXYCYCLINE HYCLATE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213075
Product Number: 003
Approval Date: Jan 3, 2022
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
Proprietary Name: DOXYCYCLINE HYCLATE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213075
Product Number: 003
Approval Date: Jan 3, 2022
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 200MG BASE
Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: DOXYCYCLINE HYCLATE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213075
Product Number: 004
Approval Date: Jan 3, 2022
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: DOXYCYCLINE HYCLATE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213075
Product Number: 004
Approval Date: Jan 3, 2022
Applicant Holder Full Name: ALEMBIC PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information