Genotropin

   
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Genotropin


Drug - Genotropin
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) - Somatropin Recombinant
Multiple ingredients are in alphabetical order.

Strength - 5.8MG/VIAL
The potency of the active ingredient(s), Somatropin Recombinant. May repeat for multiple part products.

Applicant - PHARMACIA AND UPJOHN
The firm name holding legal responsibility for Genotropin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020280
The FDA assigned number to Genotropin. Format is nnnnnn.

Product Number - 006
The FDA assigned number to identify Genotropin. 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 - Aug 24, 1995
The date Genotropin 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 Genotropin. 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 Genotropin 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 Genotropin.

Genotropin