Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215133

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SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)
EQ 150MG BASE
Marketing Status: Prescription

Active Ingredient: SERTRALINE HYDROCHLORIDE
Proprietary Name: SERTRALINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215133
Product Number: 001
Approval Date: Oct 4, 2021
Applicant Holder Full Name: ALMATICA PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)
EQ 200MG BASE
Marketing Status: Prescription

Active Ingredient: SERTRALINE HYDROCHLORIDE
Proprietary Name: SERTRALINE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215133
Product Number: 002
Approval Date: Oct 4, 2021
Applicant Holder Full Name: ALMATICA PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information