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FDA Drug information

Sertraline Hydrochloride

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20230927

Version

6

Spl Product Data Elements

Sertraline Hydrochloride Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE SERTRALINE ALUMINUM OXIDE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 2 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE SILICON DIOXIDE TITANIUM DIOXIDE TRIACETIN LIGHT GREEN ROUND Z;82 Sertraline Hydrochloride Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE SERTRALINE SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE TITANIUM DIOXIDE TRIACETIN LIGHT BLUE ROUND Z;81 Sertraline Hydrochloride Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE SERTRALINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE TALC TITANIUM DIOXIDE TRIACETIN YELLOW ROUND Z;80

Application Number

ANDA077106

Brand Name

Sertraline Hydrochloride

Generic Name

Sertraline Hydrochloride

Product Ndc

65841-044

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-043-06 in bottles of 30 tablets Sertraline Hydrochloride Tablets, 25 mg 30 Tablets NDC 65841-044-06 in bottles of 30 tablets Sertraline Hydrochloride Tablets, 50 mg 30 Tablets NDC 65841-045-06 in bottles of 30 tablets Sertraline Hydrochloride Tablets, 100 mg 30 Tablets sertraline tablets 25 mg sertraline tablets 50 mg sertraline tablets 100 mg

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