Plan B


Plan B

Drug - Plan B
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) - Levonorgestrel
Multiple ingredients are in alphabetical order.

Strength - 0.75MG
The potency of the active ingredient(s), Levonorgestrel. May repeat for multiple part products.

Applicant - DURAMED
The firm name holding legal responsibility for Plan B. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021045
The FDA assigned number to Plan B. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Plan B. 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 - Jul 28, 1999
The date Plan B 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 Plan B. 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 Plan B is in. Format is RX, OTC, DISCN.

Applicant Full Name - Duramed Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Plan B.

Plan B