Butalbital, Acetaminophen, Caffeine
Drug - Butalbital, Acetaminophen, Caffeine
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 -
325MG;50MG;40MG
The potency of the active ingredient(s), Acetaminophen; Butalbital; Caffeine. May repeat for multiple part products.
Applicant -
MUTUAL PHARM
The firm name holding legal responsibility for Butalbital, Acetaminophen, Caffeine. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
040601
The FDA assigned number to Butalbital, Acetaminophen, Caffeine. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Butalbital, Acetaminophen, Caffeine. 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 -
Jul 29, 2005
The date Butalbital, Acetaminophen, Caffeine 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 Butalbital, Acetaminophen, Caffeine. 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 Butalbital, Acetaminophen, Caffeine is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Mutual Pharmaceutical Co Inc
The full name of the firm holding legal responsibility for the new application of Butalbital, Acetaminophen, Caffeine.
Butalbital, Acetaminophen, Caffeine
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, Acetaminophen And Caffeine 500mg;50mg;40mg Tablet; Oral Butalbital, Acetaminophen And Caffeine 325mg;50mg;40mg Tablet; Oral Butalbital, Acetaminophen And Caffeine 325mg;50mg;40mg Tablet; Oral Butalbital, Acetaminophen And Caffeine 750mg;50mg;40mg Tablet; Oral
NewDrugInformation
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