Procardia Xl

   
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Procardia Xl


Drug - Procardia Xl
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 - 90MG
The potency of the active ingredient(s), Nifedipine. May repeat for multiple part products.

Applicant - PFIZER
The firm name holding legal responsibility for Procardia Xl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019684
The FDA assigned number to Procardia Xl. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Procardia Xl. 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 6, 1989
The date Procardia Xl 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 Procardia Xl. 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 Procardia Xl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pfizer Laboratories Div Pfizer Inc
The full name of the firm holding legal responsibility for the new application of Procardia Xl.

Procardia Xl