Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050641

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

Active Ingredient: DOXYCYCLINE
Proprietary Name: MONODOX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050641
Product Number: 002
Approval Date: Feb 10, 1992
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MONODOX (DOXYCYCLINE)
EQ 75MG BASE
Marketing Status: Prescription

Active Ingredient: DOXYCYCLINE
Proprietary Name: MONODOX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050641
Product Number: 003
Approval Date: Oct 18, 2006
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MONODOX (DOXYCYCLINE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: DOXYCYCLINE
Proprietary Name: MONODOX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050641
Product Number: 001
Approval Date: Dec 29, 1989
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

MONODOX (DOXYCYCLINE)
EQ 150MG BASE
Marketing Status: Prescription

Active Ingredient: DOXYCYCLINE
Proprietary Name: MONODOX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N050641
Product Number: 004
Approval Date: Feb 17, 2022
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information