Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205931

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ACTICLATE (DOXYCYCLINE HYCLATE)
EQ 75MG BASE
Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: ACTICLATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 75MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N205931
Product Number: 001
Approval Date: Jul 25, 2014
Applicant Holder Full Name: ALMIRALL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
ACTICLATE (DOXYCYCLINE HYCLATE)
EQ 150MG BASE
Marketing Status: Prescription
Active Ingredient: DOXYCYCLINE HYCLATE
Proprietary Name: ACTICLATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N205931
Product Number: 002
Approval Date: Jul 25, 2014
Applicant Holder Full Name: ALMIRALL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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