Theophyl

   
Google
 
Web NewDrugInformation.com

Theophyl


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

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

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

Strength - 100MG
The potency of the active ingredient(s), Theophylline. May repeat for multiple part products.

Applicant - ORTHO MCNEIL PHARM
The firm name holding legal responsibility for Theophyl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 086506
The FDA assigned number to Theophyl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Theophyl. 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 - Sep 12, 1985
The date Theophyl 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 Theophyl. 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 Theophyl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ortho Mcneil Pharmaceutical Inc
The full name of the firm holding legal responsibility for the new application of Theophyl.

Theophyl