Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050795

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DORYX (DOXYCYCLINE HYCLATE)
EQ 50MG BASE
Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: DORYX
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050795
Product Number: 006
Approval Date: Dec 19, 2014
Applicant Holder Full Name: MAYNE PHARMA INTERNATIONAL PTY LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DORYX (DOXYCYCLINE HYCLATE)
EQ 75MG BASE
Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: DORYX
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050795
Product Number: 001
Approval Date: May 6, 2005
Applicant Holder Full Name: MAYNE PHARMA INTERNATIONAL PTY LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DORYX (DOXYCYCLINE HYCLATE)
EQ 80MG BASE
Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: DORYX
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 80MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050795
Product Number: 004
Approval Date: Apr 11, 2013
Applicant Holder Full Name: MAYNE PHARMA INTERNATIONAL PTY LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DORYX (DOXYCYCLINE HYCLATE)
EQ 100MG BASE
Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: DORYX
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050795
Product Number: 002
Approval Date: May 6, 2005
Applicant Holder Full Name: MAYNE PHARMA INTERNATIONAL PTY LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DORYX (DOXYCYCLINE HYCLATE)
EQ 150MG BASE
Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: DORYX
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050795
Product Number: 003
Approval Date: Jun 20, 2008
Applicant Holder Full Name: MAYNE PHARMA INTERNATIONAL PTY LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DORYX (DOXYCYCLINE HYCLATE)
EQ 200MG BASE
Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: DORYX
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N050795
Product Number: 005
Approval Date: Apr 11, 2013
Applicant Holder Full Name: MAYNE PHARMA INTERNATIONAL PTY LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DORYX MPC (DOXYCYCLINE HYCLATE)
EQ 120MG BASE
Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: DORYX MPC
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 120MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N050795
Product Number: 008
Approval Date: May 20, 2016
Applicant Holder Full Name: MAYNE PHARMA INTERNATIONAL PTY LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
DORYX MPC (DOXYCYCLINE HYCLATE)
EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Marketing Status: Discontinued
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: DORYX MPC
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050795
Product Number: 007
Approval Date: May 20, 2016
Applicant Holder Full Name: MAYNE PHARMA INTERNATIONAL PTY LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

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