Milrinone Lactate

   
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Milrinone Lactate


Drug - Milrinone Lactate
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 - MAYNE PHARMA USA
The firm name holding legal responsibility for Milrinone Lactate. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075830
The FDA assigned number to Milrinone Lactate. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Milrinone Lactate. 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 - May 28, 2002
The date Milrinone Lactate 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 Milrinone Lactate. 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 Milrinone Lactate is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mayne Pharma Usa Inc
The full name of the firm holding legal responsibility for the new application of Milrinone Lactate.

Milrinone Lactate