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Drug - Dtic-dome
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) - Dacarbazine
Multiple ingredients are in alphabetical order.

Strength - 200MG/VIAL
The potency of the active ingredient(s), Dacarbazine. May repeat for multiple part products.

Applicant - BAYER PHARMS
The firm name holding legal responsibility for Dtic-dome. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017575
The FDA assigned number to Dtic-dome. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Dtic-dome. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AP
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Approved Prior to Jan 1, 1982
The date Dtic-dome 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 Dtic-dome. 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 Dtic-dome is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bayer Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Dtic-dome.