Trivora-21
Drug - Trivora-21
The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL-21
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Ethinyl Estradiol; Levonorgestrel
Multiple ingredients are in alphabetical order.
Strength -
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
The potency of the active ingredient(s), Ethinyl Estradiol; Levonorgestrel. May repeat for multiple part products.
Applicant -
WATSON LABS
The firm name holding legal responsibility for Trivora-21. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
074538
The FDA assigned number to Trivora-21. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Trivora-21. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Dec 18, 1997
The date Trivora-21 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) -
No
The pioneer or innovator of Trivora-21. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
DISCN
The group or category of approved drugs Trivora-21 is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Watson Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Trivora-21.
Trivora-21
Levlite 0.02mg;0.1mg Tablet; Oral-21 Levonorgestrel And Ethinyl Estradiol 0.02mg;0.1mg Tablet; Oral-21 Levora 0.15/30-21 0.03mg;0.15mg Tablet; Oral-21 Nordette-21 0.03mg;0.15mg Tablet; Oral-21 Portia-21 0.03mg;0.15mg Tablet; Oral-21 Triphasil-21 0.03mg,0.04mg,0.03mg;0.05mg,0.075mg,0.125mg Tablet; Oral-21 Trivora-21 0.03mg,0.04mg,0.03mg;0.05mg,0.075mg,0.125mg Tablet; Oral-21 Aviane-21 0.02mg;0.1mg Tablet; Oral-21 Enpresse-21 0.03mg,0.04mg,0.03mg;0.05mg,0.075mg,0.125mg Tablet; Oral-21 Lessina-21 0.02mg;0.1mg Tablet; Oral-21
NewDrugInformation
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