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FDA Drug information

Tadalafil

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


Effective Time

20240812

Version

4

Spl Product Data Elements

Tadalafil Tadalafil TADALAFIL TADALAFIL CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE TALC TITANIUM DIOXIDE TRIACETIN WHITE CAPSULE T;1 Tadalafil Tadalafil TADALAFIL TADALAFIL CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE TALC TITANIUM DIOXIDE TRIACETIN YELLOW CAPSULE 898 Tadalafil Tadalafil TADALAFIL TADALAFIL CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE TALC TITANIUM DIOXIDE TRIACETIN YELLOW OVAL 899 Tadalafil Tadalafil TADALAFIL TADALAFIL CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE TALC TITANIUM DIOXIDE TRIACETIN YELLOW OVAL 897

Application Number

ANDA206693

Brand Name

Tadalafil

Generic Name

Tadalafil

Product Ndc

70771-1478

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1475-3 in bottle of 30 tablets Tadalafil Tablets USP, 2.5 mg Rx Only 30 tablets NDC 70771-1476-3 in bottle of 30 tablets Tadalafil Tablets USP, 5 mg Rx Only 30 tablets NDC 70771-1477-3 in bottle of 30 tablets Tadalafil Tablets USP, 10 mg Rx Only 30 tablets NDC 70771-1478-3 in bottle of 30 tablets Tadalafil Tablets USP, 20 mg Rx Only 30 tablets 2.5 mg label 5 mg 10 mg 20 mg

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