Orgaran

   
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Orgaran


Drug - Orgaran
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) - Danaparoid Sodium
Multiple ingredients are in alphabetical order.

Strength - 750 UNITS/0.6ML
The potency of the active ingredient(s), Danaparoid Sodium. May repeat for multiple part products.

Applicant - ORGANON USA INC
The firm name holding legal responsibility for Orgaran. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020430
The FDA assigned number to Orgaran. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Orgaran. 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 - Dec 24, 1996
The date Orgaran 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 Orgaran. 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 Orgaran is in. Format is RX, OTC, DISCN.

Applicant Full Name - Organon Usa Inc
The full name of the firm holding legal responsibility for the new application of Orgaran.

Orgaran