Dynabac
Drug - Dynabac
The trade name of the product as shown on the labeling.
Dosage -
TABLET, DELAYED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Dirithromycin
Multiple ingredients are in alphabetical order.
Strength -
250MG
The potency of the active ingredient(s), Dirithromycin. May repeat for multiple part products.
Applicant -
LILLY RES LABS
The firm name holding legal responsibility for Dynabac. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
050678
The FDA assigned number to Dynabac. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Dynabac. 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 -
Jun 19, 1995
The date Dynabac 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) -
No
The pioneer or innovator of Dynabac. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
DISCN
The group or category of approved drugs Dynabac is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Lilly Research Laboratories
The full name of the firm holding legal responsibility for the new application of Dynabac.
Dynabac
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