Truphylline

   
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Truphylline


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

Dosage - SUPPOSITORY; RECTAL
The product dosage form and route separated by a semi-colon.

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

Strength - 500MG
The potency of the active ingredient(s), Aminophylline. May repeat for multiple part products.

Applicant - G AND W LABS
The firm name holding legal responsibility for Truphylline. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 085498
The FDA assigned number to Truphylline. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Truphylline. 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 - Jan 3, 1983
The date Truphylline 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 Truphylline. 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 Truphylline is in. Format is RX, OTC, DISCN.

Applicant Full Name - G And W Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Truphylline.

Truphylline