Baclofen

   
Google
 
Web NewDrugInformation.com

Baclofen


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

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

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

Strength - 20MG
The potency of the active ingredient(s), Baclofen. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 072825
The FDA assigned number to Baclofen. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Baclofen. 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 - Sep 18, 1991
The date Baclofen 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 Baclofen. 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 Baclofen is in. Format is RX, OTC, DISCN.

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

Baclofen