Norpace Cr

   
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Norpace Cr


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

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

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

Strength - EQ 150MG BASE
The potency of the active ingredient(s), Disopyramide Phosphate. May repeat for multiple part products.

Applicant - GD SEARLE LLC
The firm name holding legal responsibility for Norpace Cr. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018655
The FDA assigned number to Norpace Cr. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Norpace Cr. 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 - Jul 20, 1982
The date Norpace Cr 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 Norpace Cr. 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 Norpace Cr is in. Format is RX, OTC, DISCN.

Applicant Full Name - Gd Searle Llc
The full name of the firm holding legal responsibility for the new application of Norpace Cr.

Norpace Cr