MedPath
FDA Product

DOTTI

Product approved by U.S. Food and Drug Administration (US)

Basic Information

DOTTI

72162-2036

Regulatory Information

72162-2036

ANDA211293

C73584

May 31, 2023

USA

These highlights do not include all the information needed to use DOTTI safely and effectively. See full prescribing information for DOTTI. DOTTI (estradiol transdermal system) Initial U.S. Approval: 1996

HUMAN PRESCRIPTION DRUG LABEL

100

Company Information

171714327

Active Ingredients

ESTRADIOL

Quantity: 0.1 mg in 1 d

Code: 4TI98Z838E

Class Code: ACTIB

DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)

Code: 83D19O7250

Class Code: IACT

OLEYL ALCOHOL

Code: 172F2WN8DV

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

DIPROPYLENE GLYCOL

Code: E107L85C40

Class Code: IACT

Active Moieties

ESTRADIOL

Code: 4TI98Z838E

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