Vivelle-dot
Drug - Vivelle-dot
The trade name of the product as shown on the labeling.
Dosage -
FILM, EXTENDED RELEASE; TRANSDERMAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Estradiol
Multiple ingredients are in alphabetical order.
Strength -
0.075MG/24HR
The potency of the active ingredient(s), Estradiol. May repeat for multiple part products.
Applicant -
NOVARTIS
The firm name holding legal responsibility for Vivelle-dot. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020538
The FDA assigned number to Vivelle-dot. Format is nnnnnn.
Product Number -
007
The FDA assigned number to identify Vivelle-dot. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
BX
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Jan 8, 1999
The date Vivelle-dot was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".
Reference Listed Drug (RLD) -
Yes
The pioneer or innovator of Vivelle-dot. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
RX
The group or category of approved drugs Vivelle-dot is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Vivelle-dot.
Vivelle-dot
Vivelle-dot 0.025mg/24hr Film, Extended Release; Transdermal Vivelle-dot 0.0375mg/24hr Film, Extended Release; Transdermal Vivelle-dot 0.05mg/24hr Film, Extended Release; Transdermal Vivelle-dot 0.075mg/24hr Film, Extended Release; Transdermal Menostar 0.014mg/24hr Film, Extended Release; Transdermal Vivelle 0.025mg/24hr Film, Extended Release; Transdermal Vivelle 0.0375mg/24hr Film, Extended Release; Transdermal Vivelle 0.05mg/24hr Film, Extended Release; Transdermal Vivelle 0.075mg/24hr Film, Extended Release; Transdermal Vivelle 0.1mg/24hr Film, Extended Release; Transdermal
NewDrugInformation
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