Lovenox

   
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Lovenox


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

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

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

Strength - 300MG/3ML (100MG/ML)
The potency of the active ingredient(s), Enoxaparin Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020164
The FDA assigned number to Lovenox. Format is nnnnnn.

Product Number - 009
The FDA assigned number to identify Lovenox. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Jan 23, 2003
The date Lovenox 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 Lovenox. 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 Lovenox is in. Format is RX, OTC, DISCN.

Applicant Full Name - Aventis Pharmaceutical Products Inc
The full name of the firm holding legal responsibility for the new application of Lovenox.

Lovenox