Drug - Matulane
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) - Procarbazine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 50MG BASE
The potency of the active ingredient(s), Procarbazine Hydrochloride. May repeat for multiple part products.

Applicant - SIGMA TAU
The firm name holding legal responsibility for Matulane. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 016785
The FDA assigned number to Matulane. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Matulane. 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 Matulane 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 Matulane. 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 Matulane is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sigma Tau Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Matulane.