Uni-dur
Drug - Uni-dur
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 -
400MG
The potency of the active ingredient(s), Theophylline. May repeat for multiple part products.
Applicant -
SCHERING
The firm name holding legal responsibility for Uni-dur. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
089822
The FDA assigned number to Uni-dur. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Uni-dur. 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 4, 1995
The date Uni-dur 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 Uni-dur. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
DISCN
The group or category of approved drugs Uni-dur is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Schering Corp Sub Schering Plough Corp
The full name of the firm holding legal responsibility for the new application of Uni-dur.
Uni-dur
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 Uni-dur 400mg 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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