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FDA Drug information

Bosentan

Read time: 1 mins
Marketing start date: 07 May 2024
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Summary of product characteristics


Effective Time

20230920

Version

5

Spl Product Data Elements

Bosentan Bosentan BOSENTAN BOSENTAN ANHYDROUS ETHYLCELLULOSE, UNSPECIFIED FERRIC OXIDE RED FERRIC OXIDE YELLOW GLYCERYL DIBEHENATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TALC TITANIUM DIOXIDE TRIACETIN LIGHT PINK BICONVEX 446 Bosentan Bosentan BOSENTAN BOSENTAN ANHYDROUS ETHYLCELLULOSE, UNSPECIFIED FERRIC OXIDE RED FERRIC OXIDE YELLOW GLYCERYL DIBEHENATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE POVIDONE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN TALC TITANIUM DIOXIDE TRIACETIN LIGHT PINK BICONVEX 447

Application Number

ANDA207760

Brand Name

Bosentan

Generic Name

Bosentan

Product Ndc

70771-1018

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1017-6 Bosentan tablets, 62.5 mg 60 tablets Rx only NDC 70771-1018-6 Bosentan tablets, 125 mg 60 tablets Rx only Bosentan tablets Bosentan tablets

Spl Medguide

SPL MEDGUIDE

Drug section

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