Didronel
Drug - Didronel
The trade name of the product as shown on the labeling.
Dosage -
INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Etidronate Disodium
Multiple ingredients are in alphabetical order.
Strength -
50MG/ML
The potency of the active ingredient(s), Etidronate Disodium. May repeat for multiple part products.
Applicant -
MGI PHARMA INC
The firm name holding legal responsibility for Didronel. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
019545
The FDA assigned number to Didronel. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Didronel. 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 -
Apr 20, 1987
The date Didronel 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 Didronel. 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 Didronel 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 Didronel.
Didronel
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