Lantus

   
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Lantus


Drug - Lantus
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) - Insulin Glargine Recombinant
Multiple ingredients are in alphabetical order.

Strength - 100 UNITS/ML
The potency of the active ingredient(s), Insulin Glargine Recombinant. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021081
The FDA assigned number to Lantus. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Lantus. 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 - Apr 20, 2000
The date Lantus 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 Lantus. 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 Lantus is in. Format is RX, OTC, DISCN.

Applicant Full Name - Aventis Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Lantus.

Lantus