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FDA Product

Sertraline hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Sertraline hydrochloride

70010-204

Regulatory Information

70010-204

ANDA078403

C73584

April 6, 2023

USA

Sertraline Hydrochloride tablets 25 mg, 50 mg, and 100 mg Tablets

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

079825711

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED

Code: 2165RE0K14

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A

Code: H8AV0SQX4D

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

HYPROMELLOSE 2910 (5 MPA.S)

Code: R75537T0T4

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 2

Code: L06K8R7DQK

Class Code: IACT

SERTRALINE HYDROCHLORIDE

Quantity: 50 mg in 1 1

Code: UTI8907Y6X

Class Code: ACTIM

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS

Code: L11K75P92J

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

SERTRALINE

Code: QUC7NX6WMB

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