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FDA Drug information

Teriflunomide

Read time: 1 mins
Marketing start date: 28 Apr 2024
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Summary of product characteristics


Effective Time

20230927

Version

2

Spl Product Data Elements

Teriflunomide Teriflunomide TERIFLUNOMIDE TERIFLUNOMIDE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TITANIUM DIOXIDE WHITE TO OFF WHITE ROUND 1114 Teriflunomide Teriflunomide TERIFLUNOMIDE TERIFLUNOMIDE CELLULOSE, MICROCRYSTALLINE FD&C BLUE NO. 2 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TITANIUM DIOXIDE BLUE TO LIGHT BLUE ROUND 1115

Application Number

ANDA209668

Brand Name

Teriflunomide

Generic Name

Teriflunomide

Product Ndc

70771-1010

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1010-3 Teriflunomide Tablets, 7 mg 30 Tablets Rx only NDC 70771-1011-3 Teriflunomide Tablets, 14 mg 30 Tablets Rx only 7 mg 14 mg

Spl Medguide

SPL MEDGUIDE

Drug section

Brain nerve cells
Brain nerve cells
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Disclaimer

The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

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