Drug - Alkeran
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) - Melphalan Hydrochloride
Multiple ingredients are in alphabetical order.

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

The firm name holding legal responsibility for Alkeran. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020207
The FDA assigned number to Alkeran. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Alkeran. 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 - Nov 18, 1992
The date Alkeran 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 Alkeran. 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 Alkeran is in. Format is RX, OTC, DISCN.

Applicant Full Name - Glaxosmithkline
The full name of the firm holding legal responsibility for the new application of Alkeran.