Enovid-e

   
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Enovid-e


Drug - Enovid-e
The trade name of the product as shown on the labeling.

Dosage - TABLET; ORAL-20
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Mestranol; Norethynodrel
Multiple ingredients are in alphabetical order.

Strength - 0.1MG;2.5MG
The potency of the active ingredient(s), Mestranol; Norethynodrel. May repeat for multiple part products.

Applicant - GD SEARLE LLC
The firm name holding legal responsibility for Enovid-e. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 010976
The FDA assigned number to Enovid-e. Format is nnnnnn.

Product Number - 006
The FDA assigned number to identify Enovid-e. 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 Enovid-e 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 Enovid-e. 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 Enovid-e 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 Enovid-e.

Enovid-e