Butalbital; Acetaminophen; And Caffeine With Codeine Phosphate

   
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Butalbital; Acetaminophen; And Caffeine With Codeine Phosphate


Drug - Butalbital; Acetaminophen; And Caffeine With Codeine Phosphate
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) - Acetaminophen; Butalbital; Caffeine; Codeine Phosphate
Multiple ingredients are in alphabetical order.

Strength - 325MG;50MG;40MG;30MG
The potency of the active ingredient(s), Acetaminophen; Butalbital; Caffeine; Codeine Phosphate. May repeat for multiple part products.

Applicant - WEST WARD
The firm name holding legal responsibility for Butalbital; Acetaminophen; And Caffeine With Codeine Phosphate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075618
The FDA assigned number to Butalbital; Acetaminophen; And Caffeine With Codeine Phosphate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Butalbital; Acetaminophen; And Caffeine With Codeine Phosphate. 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 - Mar 23, 2001
The date Butalbital; Acetaminophen; And Caffeine With Codeine Phosphate 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 Butalbital; Acetaminophen; And Caffeine With Codeine Phosphate. 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 Butalbital; Acetaminophen; And Caffeine With Codeine Phosphate is in. Format is RX, OTC, DISCN.

Applicant Full Name - West Ward Pharmaceutical Corp
The full name of the firm holding legal responsibility for the new application of Butalbital; Acetaminophen; And Caffeine With Codeine Phosphate.

Butalbital; Acetaminophen; And Caffeine With Codeine Phosphate