Primacor

   
Google
 
Web NewDrugInformation.com

Primacor


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

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

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

Strength - EQ 1MG BASE/ML
The potency of the active ingredient(s), Milrinone Lactate. May repeat for multiple part products.

Applicant - SANOFI SYNTHELABO
The firm name holding legal responsibility for Primacor. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019436
The FDA assigned number to Primacor. Format is nnnnnn.

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

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

Approval Date - Dec 31, 1987
The date Primacor 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 Primacor. 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 Primacor is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sanofi Synthelabo Inc
The full name of the firm holding legal responsibility for the new application of Primacor.

Primacor