T-phyl

   
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T-phyl


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

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 200MG
The potency of the active ingredient(s), Theophylline. May repeat for multiple part products.

Applicant - PURDUE FREDERICK
The firm name holding legal responsibility for T-phyl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 088253
The FDA assigned number to T-phyl. Format is nnnnnn.

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

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

Approval Date - Aug 17, 1983
The date T-phyl 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 T-phyl. 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 T-phyl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Purdue Frederick Co
The full name of the firm holding legal responsibility for the new application of T-phyl.

T-phyl