Sorine
Drug - Sorine
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) -
Sotalol Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
160MG
The potency of the active ingredient(s), Sotalol Hydrochloride. May repeat for multiple part products.
Applicant -
UPSHER SMITH
The firm name holding legal responsibility for Sorine. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
075500
The FDA assigned number to Sorine. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Sorine. 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 -
Apr 27, 2001
The date Sorine 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 Sorine. 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 Sorine is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Upsher Smith Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Sorine.
Sorine
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