Bretylium Tosylate


Bretylium Tosylate

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

The product dosage form and route separated by a semi-colon.

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

Strength - 50MG/ML
The potency of the active ingredient(s), Bretylium Tosylate. May repeat for multiple part products.

The firm name holding legal responsibility for Bretylium Tosylate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 071152
The FDA assigned number to Bretylium Tosylate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Bretylium Tosylate. 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 - Aug 10, 1987
The date Bretylium Tosylate 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 Bretylium Tosylate. 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 Bretylium Tosylate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Astrazeneca Lp
The full name of the firm holding legal responsibility for the new application of Bretylium Tosylate.

Bretylium Tosylate