Butisol Sodium

   
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Butisol Sodium


Drug - Butisol Sodium
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 - MEDPOINTE PHARM HLC
The firm name holding legal responsibility for Butisol Sodium. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 000793
The FDA assigned number to Butisol Sodium. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Butisol Sodium. 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 Butisol Sodium 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 Butisol Sodium. 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 Butisol Sodium is in. Format is RX, OTC, DISCN.

Applicant Full Name - Medpointe Pharmaceuticals Medpointe Healthcare Inc
The full name of the firm holding legal responsibility for the new application of Butisol Sodium.

Butisol Sodium