Cardene

   
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Cardene


Drug - Cardene
The trade name of the product as shown on the labeling.

Dosage - CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Nicardipine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 30MG
The potency of the active ingredient(s), Nicardipine Hydrochloride. May repeat for multiple part products.

Applicant - ROCHE PALO
The firm name holding legal responsibility for Cardene. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019488
The FDA assigned number to Cardene. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Cardene. 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 - Dec 21, 1988
The date Cardene 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) - Yes
The pioneer or innovator of Cardene. 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 Cardene is in. Format is RX, OTC, DISCN.

Applicant Full Name - Roche Palo Alto Llc
The full name of the firm holding legal responsibility for the new application of Cardene.

Cardene