Pacerone
Drug - Pacerone
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) -
Amiodarone Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
100MG
The potency of the active ingredient(s), Amiodarone Hydrochloride. May repeat for multiple part products.
Applicant -
UPSHER SMITH
The firm name holding legal responsibility for Pacerone. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
075135
The FDA assigned number to Pacerone. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Pacerone. Each strength is a separate product. May repeat for multiple part products. Format is nnn.
Therapeutic Equivalence (TE) Code -
AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.
Approval Date -
Apr 12, 2005
The date Pacerone 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 Pacerone. 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 Pacerone 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 Pacerone.
Pacerone
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