Cialis
Drug - Cialis
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) -
Tadalafil
Multiple ingredients are in alphabetical order.
Strength -
5MG
The potency of the active ingredient(s), Tadalafil. May repeat for multiple part products.
Applicant -
LILLY ICOS
The firm name holding legal responsibility for Cialis. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
021368
The FDA assigned number to Cialis. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Cialis. 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 -
Nov 21, 2003
The date Cialis 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 Cialis. 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 Cialis is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Lilly Icos Llc
The full name of the firm holding legal responsibility for the new application of Cialis.
Cialis
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