Innohep

   
Google
 
Web NewDrugInformation.com

Innohep


Drug - Innohep
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) - Tinzaparin Sodium
Multiple ingredients are in alphabetical order.

Strength - 20,000 IU/ML
The potency of the active ingredient(s), Tinzaparin Sodium. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020484
The FDA assigned number to Innohep. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Innohep. 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 - Jul 14, 2000
The date Innohep 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 Innohep. 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 Innohep is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pharmion Corp
The full name of the firm holding legal responsibility for the new application of Innohep.

Innohep