Bio-tropin

   
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Bio-tropin


Drug - Bio-tropin
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 - 4.8MG/VIAL
The potency of the active ingredient(s), Somatropin Recombinant. May repeat for multiple part products.

Applicant - FERRING
The firm name holding legal responsibility for Bio-tropin. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019774
The FDA assigned number to Bio-tropin. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Bio-tropin. 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 - May 25, 1995
The date Bio-tropin 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 Bio-tropin. 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 Bio-tropin is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ferring Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Bio-tropin.

Bio-tropin