Nicardipine Hcl

   
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Nicardipine Hcl


Drug - Nicardipine Hcl
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 - 20MG
The potency of the active ingredient(s), Nicardipine Hydrochloride. May repeat for multiple part products.

Applicant - IVAX PHARMS
The firm name holding legal responsibility for Nicardipine Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 074439
The FDA assigned number to Nicardipine Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Nicardipine Hcl. 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 10, 1996
The date Nicardipine Hcl 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 Nicardipine Hcl. 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 Nicardipine Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ivax Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Nicardipine Hcl.

Nicardipine Hcl