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
Theophylline 200mg Tablet, Extended Release; Oral Theophylline 300mg Tablet, Extended Release; Oral Theophylline 450mg Tablet, Extended Release; Oral T-phyl 200mg Tablet, Extended Release; Oral Theophylline 300mg Tablet, Extended Release; Oral Theophylline 400mg Tablet, Extended Release; Oral Theophylline 450mg Tablet, Extended Release; Oral Theophylline 600mg Tablet, Extended Release; Oral Theophylline 450mg Tablet, Extended Release; Oral Theophylline 100mg Tablet, Extended Release; Oral
NewDrugInformation
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