Sotalol Hcl


Sotalol Hcl

Drug - Sotalol Hcl
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) - Sotalol Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 120MG
The potency of the active ingredient(s), Sotalol Hydrochloride. May repeat for multiple part products.

Applicant - TEVA
The firm name holding legal responsibility for Sotalol Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075429
The FDA assigned number to Sotalol Hcl. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Sotalol Hcl. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB1
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - May 1, 2000
The date Sotalol Hcl 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 Sotalol Hcl. 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 Sotalol Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Teva Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Sotalol Hcl.

Sotalol Hcl