Norplant

   
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Norplant


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

Dosage - IMPLANT; IMPLANTATION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Levonorgestrel
Multiple ingredients are in alphabetical order.

Strength - 36MG/IMPLANT
The potency of the active ingredient(s), Levonorgestrel. May repeat for multiple part products.

Applicant - POPULATION COUNCIL
The firm name holding legal responsibility for Norplant. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019897
The FDA assigned number to Norplant. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Norplant. 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 10, 1990
The date Norplant 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 Norplant. 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 Norplant is in. Format is RX, OTC, DISCN.

Applicant Full Name - Population Council
The full name of the firm holding legal responsibility for the new application of Norplant.

Norplant