Assyro AI

Orange Book product · Brand (NDA)

ZOLOFT

SERTRALINE HYDROCHLORIDE

Brand (NDA)NDA 020990TE AARX VIATRIS
View SERTRALINE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Dec 07, 1999

Approved

Brand (NDA)

Application

AA

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 07, 1999

    26 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SERTRALINE HYDROCHLORIDE

Strength

EQ 20MG BASE/ML

Dosage form

CONCENTRATE

Route

ORAL

TE code

AA

Application

NDA 020990

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

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