Norplant Ii

   
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Norplant Ii


Drug - Norplant Ii
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 - 75MG/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 Ii. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020544
The FDA assigned number to Norplant Ii. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Norplant Ii. 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 - Nov 1, 1996
The date Norplant Ii 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 Norplant Ii. 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 Norplant Ii is in. Format is RX, OTC, DISCN.

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

Norplant Ii