Butabarbital

   
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Butabarbital


Drug - Butabarbital
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) - Butabarbital Sodium
Multiple ingredients are in alphabetical order.

Strength - 30MG
The potency of the active ingredient(s), Butabarbital Sodium. May repeat for multiple part products.

Applicant - BUNDY
The firm name holding legal responsibility for Butabarbital. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 085550
The FDA assigned number to Butabarbital. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Butabarbital. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AA
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Approved Prior to Jan 1, 1982
The date Butabarbital 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 Butabarbital. 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 Butabarbital is in. Format is RX, OTC, DISCN.

Applicant Full Name - Cm Bundy Co
The full name of the firm holding legal responsibility for the new application of Butabarbital.

Butabarbital