Theochron

   
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Theochron


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

Applicant - INWOOD LABS
The firm name holding legal responsibility for Theochron. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 088320
The FDA assigned number to Theochron. Format is nnnnnn.

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

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

Approval Date - Feb 21, 1985
The date Theochron 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 Theochron. 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 Theochron is in. Format is RX, OTC, DISCN.

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

Theochron