Drug - Ovulen-21
The trade name of the product as shown on the labeling.
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Ethynodiol Diacetate; Mestranol
Multiple ingredients are in alphabetical order.
The potency of the active ingredient(s), Ethynodiol Diacetate; Mestranol. May repeat for multiple part products.
GD SEARLE LLC
The firm name holding legal responsibility for Ovulen-21. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
The FDA assigned number to Ovulen-21. Format is nnnnnn.
Product Number -
The FDA assigned number to identify Ovulen-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 -
Approved Prior to Jan 1, 1982
The date Ovulen-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) -
The pioneer or innovator of Ovulen-21. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
The group or category of approved drugs Ovulen-21 is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Gd Searle Llc
The full name of the firm holding legal responsibility for the new application of Ovulen-21.