Serostim

   
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Serostim


Drug - Serostim
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 - 6MG/VIAL
The potency of the active ingredient(s), Somatropin Recombinant. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020604
The FDA assigned number to Serostim. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Serostim. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - BX
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Aug 23, 1996
The date Serostim 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 Serostim. 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 Serostim is in. Format is RX, OTC, DISCN.

Applicant Full Name - Serono Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Serostim.

Serostim