Acetaminophen, Butalbital And Caffeine

   
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Acetaminophen, Butalbital And Caffeine


Drug - Acetaminophen, Butalbital And 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 - GILBERT LABS
The firm name holding legal responsibility for Acetaminophen, Butalbital And Caffeine. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 087629
The FDA assigned number to Acetaminophen, Butalbital And Caffeine. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Acetaminophen, Butalbital And 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 - Nov 13, 1984
The date Acetaminophen, Butalbital And 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 Acetaminophen, Butalbital And 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 Acetaminophen, Butalbital And Caffeine is in. Format is RX, OTC, DISCN.

Applicant Full Name - Gilbert Laboratories
The full name of the firm holding legal responsibility for the new application of Acetaminophen, Butalbital And Caffeine.

Acetaminophen, Butalbital And Caffeine