Nifedipine

   
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Nifedipine


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

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 60MG
The potency of the active ingredient(s), Nifedipine. May repeat for multiple part products.

Applicant - BIOVAIL
The firm name holding legal responsibility for Nifedipine. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075289
The FDA assigned number to Nifedipine. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Nifedipine. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB2
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Sep 27, 2000
The date Nifedipine 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 Nifedipine. 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 Nifedipine is in. Format is RX, OTC, DISCN.

Applicant Full Name - Biovail Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Nifedipine.

Nifedipine