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FDA Drug information

Ambrisentan

Read time: 1 mins
Marketing start date: 26 Jan 2025
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Summary of product characteristics


Effective Time

20241125

Version

10

Spl Product Data Elements

Ambrisentan Ambrisentan AMBRISENTAN AMBRISENTAN CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE TALC TITANIUM DIOXIDE FD&C RED NO. 40 ALUMINUM OXIDE POLYVINYL ALCOHOL, UNSPECIFIED PINK ROUND 1179 Ambrisentan Ambrisentan AMBRISENTAN AMBRISENTAN CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE LECITHIN, SOYBEAN MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE TALC TITANIUM DIOXIDE POLYVINYL ALCOHOL, UNSPECIFIED OFF WHITE OVAL 1180

Application Number

ANDA210058

Brand Name

Ambrisentan

Generic Name

Ambrisentan

Product Ndc

70771-1364

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1363-3 Ambrisentan Tablets, 5 mg 30 Tablets Rx only NDC 70771-1364-3 Ambrisentan Tablets, 10 mg 30 Tablets Rx only labels label

Spl Medguide

SPL MEDGUIDE

Drug section

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