Librelease

   
Google
 
Web NewDrugInformation.com

Librelease


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

Dosage - CAPSULE, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 30MG
The potency of the active ingredient(s), Chlordiazepoxide. May repeat for multiple part products.

Applicant - VALEANT PHARM INTL
The firm name holding legal responsibility for Librelease. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017813
The FDA assigned number to Librelease. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Librelease. 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, 1983
The date Librelease 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 Librelease. 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 Librelease is in. Format is RX, OTC, DISCN.

Applicant Full Name - Valeant Pharmaceuticals International
The full name of the firm holding legal responsibility for the new application of Librelease.

Librelease