Heparin Sodium

   
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Heparin Sodium


Drug - Heparin Sodium
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) - Heparin Sodium
Multiple ingredients are in alphabetical order.

Strength - 40,000 UNITS/ML
The potency of the active ingredient(s), Heparin Sodium. May repeat for multiple part products.

Applicant - AKORN
The firm name holding legal responsibility for Heparin Sodium. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017486
The FDA assigned number to Heparin Sodium. Format is nnnnnn.

Product Number - 005
The FDA assigned number to identify Heparin Sodium. 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 - Approved Prior to Jan 1, 1982
The date Heparin Sodium 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 Heparin Sodium. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Heparin Sodium is in. Format is RX, OTC, DISCN.

Applicant Full Name - Akorn Inc
The full name of the firm holding legal responsibility for the new application of Heparin Sodium.

Heparin Sodium