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

The product dosage form and route separated by a semi-colon.

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

Strength - 5,000 IU/0.2ML
The potency of the active ingredient(s), Dalteparin Sodium. May repeat for multiple part products.

The firm name holding legal responsibility for Fragmin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020287
The FDA assigned number to Fragmin. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Fragmin. 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 - Mar 18, 1996
The date Fragmin 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 Fragmin. 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 Fragmin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pharmacia And Upjohn Co
The full name of the firm holding legal responsibility for the new application of Fragmin.