Buticaps

   
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Buticaps


Drug - Buticaps
The trade name of the product as shown on the labeling.

Dosage - CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Butabarbital Sodium
Multiple ingredients are in alphabetical order.

Strength - 100MG
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 Buticaps. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 085381
The FDA assigned number to Buticaps. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Buticaps. 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 - Approved Prior to Jan 1, 1982
The date Buticaps 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 Buticaps. 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 Buticaps 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 Buticaps.

Buticaps