Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209521

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SEYSARA (SARECYCLINE HYDROCHLORIDE)
EQ 60MG BASE
Marketing Status: Prescription

Active Ingredient: SARECYCLINE HYDROCHLORIDE
Proprietary Name: SEYSARA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 60MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209521
Product Number: 001
Approval Date: Oct 1, 2018
Applicant Holder Full Name: ALMIRALL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SEYSARA (SARECYCLINE HYDROCHLORIDE)
EQ 100MG BASE
Marketing Status: Prescription

Active Ingredient: SARECYCLINE HYDROCHLORIDE
Proprietary Name: SEYSARA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209521
Product Number: 002
Approval Date: Oct 1, 2018
Applicant Holder Full Name: ALMIRALL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SEYSARA (SARECYCLINE HYDROCHLORIDE)
EQ 150MG BASE
Marketing Status: Prescription

Active Ingredient: SARECYCLINE HYDROCHLORIDE
Proprietary Name: SEYSARA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209521
Product Number: 003
Approval Date: Oct 1, 2018
Applicant Holder Full Name: ALMIRALL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information