Elixophyllin

   
Google
 
Web NewDrugInformation.com

Elixophyllin


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

Dosage - CAPSULE; 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 - FOREST LABS
The firm name holding legal responsibility for Elixophyllin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 083921
The FDA assigned number to Elixophyllin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Elixophyllin. 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 - Jul 31, 1984
The date Elixophyllin 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 Elixophyllin. 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 Elixophyllin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Forest Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Elixophyllin.

Elixophyllin