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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020990

ZOLOFT (SERTRALINE HYDROCHLORIDE)
EQ 20MG BASE/ML
Marketing Status: Prescription
Active Ingredient: SERTRALINE HYDROCHLORIDE
Proprietary Name: ZOLOFT
Dosage Form; Route of Administration: CONCENTRATE; ORAL
Strength: EQ 20MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N020990
Product Number: 001
Approval Date: Dec 7, 1999
Applicant Holder Full Name: VIATRIS SPECIALTY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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