Gliadel
Drug - Gliadel
The trade name of the product as shown on the labeling.
Dosage -
IMPLANT; INTRACRANIAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Carmustine
Multiple ingredients are in alphabetical order.
Strength -
7.7MG
The potency of the active ingredient(s), Carmustine. May repeat for multiple part products.
Applicant -
MGI PHARMA INC
The firm name holding legal responsibility for Gliadel. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020637
The FDA assigned number to Gliadel. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Gliadel. 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 -
Sep 23, 1996
The date Gliadel 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 Gliadel. 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 Gliadel is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Mgi Pharma Inc
The full name of the firm holding legal responsibility for the new application of Gliadel.
Gliadel
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