Sedapap

   
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Sedapap


Drug - Sedapap
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
Multiple ingredients are in alphabetical order.

Strength - 650MG;50MG
The potency of the active ingredient(s), Acetaminophen; Butalbital. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 088944
The FDA assigned number to Sedapap. Format is nnnnnn.

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

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

Approval Date - Oct 17, 1985
The date Sedapap 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 Sedapap. 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 Sedapap is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mayrand Inc
The full name of the firm holding legal responsibility for the new application of Sedapap.

Sedapap