Corgard
Drug - Corgard
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) -
Nadolol
Multiple ingredients are in alphabetical order.
Strength -
20MG
The potency of the active ingredient(s), Nadolol. May repeat for multiple part products.
Applicant -
APOTHECON
The firm name holding legal responsibility for Corgard. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
018063
The FDA assigned number to Corgard. Format is nnnnnn.
Product Number -
005
The FDA assigned number to identify Corgard. 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 -
Oct 28, 1986
The date Corgard 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 Corgard. 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 Corgard is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Apothecon Inc Div Bristol Myers Squibb
The full name of the firm holding legal responsibility for the new application of Corgard.
Corgard
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