Butalbital, Aspirin & Caffeine

   
Google
 
Web NewDrugInformation.com

Butalbital, Aspirin & Caffeine


Drug - Butalbital, Aspirin & 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) - Aspirin; Butalbital; Caffeine
Multiple ingredients are in alphabetical order.

Strength - 325MG;50MG;40MG
The potency of the active ingredient(s), Aspirin; Butalbital; Caffeine. May repeat for multiple part products.

Applicant - HALSEY
The firm name holding legal responsibility for Butalbital, Aspirin & Caffeine. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 089448
The FDA assigned number to Butalbital, Aspirin & Caffeine. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Butalbital, Aspirin & Caffeine. 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 - Dec 1, 1986
The date Butalbital, Aspirin & 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, Aspirin & Caffeine. 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 Butalbital, Aspirin & Caffeine is in. Format is RX, OTC, DISCN.

Applicant Full Name - Halsey Drug Co Inc
The full name of the firm holding legal responsibility for the new application of Butalbital, Aspirin & Caffeine.

Butalbital, Aspirin & Caffeine