Esgic-plus
Drug - Esgic-plus
The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Acetaminophen; Butalbital; Caffeine
Multiple ingredients are in alphabetical order.
Strength -
500MG;50MG;40MG
The potency of the active ingredient(s), Acetaminophen; Butalbital; Caffeine. May repeat for multiple part products.
Applicant -
MIKART
The firm name holding legal responsibility for Esgic-plus. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
089451
The FDA assigned number to Esgic-plus. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Esgic-plus. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
May 23, 1988
The date Esgic-plus 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 Esgic-plus. 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 Esgic-plus is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Mikart Inc
The full name of the firm holding legal responsibility for the new application of Esgic-plus.
Esgic-plus
Butalbital, Acetaminophen And Caffeine 325mg;50mg;40mg Tablet; Oral Butalbital, Acetaminophen And Caffeine 500mg;50mg;40mg Tablet; Oral Butalbital, Acetaminophen And Caffeine 500mg;50mg;40mg Tablet; Oral Butalbital, Acetaminophen And Caffeine 325mg;50mg;40mg Tablet; Oral Butalbital, Acetaminophen, And Caffeine 500mg;50mg;40mg Tablet; Oral Butalbital, Acetaminophen, Caffeine 325mg;50mg;40mg Tablet; Oral Butalbital, Apap, And Caffeine 325mg;50mg;40mg Tablet; Oral Esgic 325mg;50mg;40mg Tablet; Oral Esgic-plus 500mg;50mg;40mg Tablet; Oral Butalbital, Acetaminophen And Caffeine 750mg;50mg;40mg Tablet; Oral
NewDrugInformation
|