Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207494

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DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
EQ 50MG BASE
Marketing Status: Prescription

Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: DOXYCYCLINE HYCLATE
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207494
Product Number: 003
Approval Date: Feb 19, 2019
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
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: A207494
Product Number: 001
Approval Date: Nov 15, 2016
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
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: A207494
Product Number: 002
Approval Date: Nov 15, 2016
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information