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FDA Drug information

Emtricitabine and tenofovir disoproxil fumarate

Read time: 1 mins
Marketing start date: 26 Nov 2024
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Summary of product characteristics


Effective Time

20230926

Version

5

Spl Product Data Elements

Emtricitabine and tenofovir disoproxil fumarate Emtricitabine and tenofovir disoproxil fumarate EMTRICITABINE EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR ANHYDROUS CROSCARMELLOSE SODIUM GLYCERYL MONOCAPRYLOCAPRATE HYPROMELLOSE 2910 (5 MPA.S) KAOLIN LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE TITANIUM DIOXIDE POLYVINYL ALCOHOL, UNSPECIFIED WHITE TO OFF-WHITE 1364 Emtricitabine and tenofovir disoproxil fumarate Emtricitabine and tenofovir disoproxil fumarate EMTRICITABINE EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR ANHYDROUS CROSCARMELLOSE SODIUM GLYCERYL MONOCAPRYLOCAPRATE HYPROMELLOSE 2910 (5 MPA.S) KAOLIN LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE TITANIUM DIOXIDE POLYVINYL ALCOHOL, UNSPECIFIED WHITE TO OFF-WHITE 1365 Emtricitabine and tenofovir disoproxil fumarate Emtricitabine and tenofovir disoproxil fumarate EMTRICITABINE EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR ANHYDROUS CROSCARMELLOSE SODIUM GLYCERYL MONOCAPRYLOCAPRATE HYPROMELLOSE 2910 (5 MPA.S) KAOLIN LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE TITANIUM DIOXIDE POLYVINYL ALCOHOL, UNSPECIFIED WHITE TO OFF-WHITE modified capsule 1366 Emtricitabine and tenofovir disoproxil fumarate Emtricitabine and tenofovir disoproxil fumarate EMTRICITABINE EMTRICITABINE TENOFOVIR DISOPROXIL FUMARATE TENOFOVIR ANHYDROUS CROSCARMELLOSE SODIUM GLYCERYL MONOCAPRYLOCAPRATE HYPROMELLOSE 2910 (5 MPA.S) KAOLIN LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE STARCH, CORN SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE TITANIUM DIOXIDE POLYVINYL ALCOHOL, UNSPECIFIED off-white 1367

Application Number

ANDA212689

Brand Name

Emtricitabine and tenofovir disoproxil fumarate

Generic Name

Emtricitabine and tenofovir disoproxil fumarate

Product Ndc

70771-1709

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1620-3 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 100 mg/150 mg Rx Only 30 tablets NDC 70771-1621-3 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 133 mg/200 mg Rx Only 30 tablets NDC 70771-1622-3 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 167 mg/250 mg Rx Only 30 tablets NDC 70771-1709-3 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg Rx Only 30 tablets MFG label MFG label MFG label label

Spl Medguide

SPL MEDGUIDE

Drug section

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