Etomidate
Drug - Etomidate
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) -
Etomidate
Multiple ingredients are in alphabetical order.
Strength -
2MG/ML
The potency of the active ingredient(s), Etomidate. May repeat for multiple part products.
Applicant -
BEDFORD
The firm name holding legal responsibility for Etomidate. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
074593
The FDA assigned number to Etomidate. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Etomidate. 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 -
Nov 4, 1996
The date Etomidate 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 Etomidate. 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 Etomidate is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Bedford Laboratories Div Ben Venue Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Etomidate.
Etomidate
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