Ismelin

   
Google
 
Web NewDrugInformation.com

Ismelin


Drug - Ismelin
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) - Guanethidine Monosulfate
Multiple ingredients are in alphabetical order.

Strength - EQ 10MG SULFATE
The potency of the active ingredient(s), Guanethidine Monosulfate. May repeat for multiple part products.

Applicant - NOVARTIS
The firm name holding legal responsibility for Ismelin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 012329
The FDA assigned number to Ismelin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Ismelin. 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 - Approved Prior to Jan 1, 1982
The date Ismelin 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 Ismelin. 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 Ismelin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Ismelin.

Ismelin