Risperdal Consta

   
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Risperdal Consta


Drug - Risperdal Consta
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INTRAMUSCULAR
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Risperidone
Multiple ingredients are in alphabetical order.

Strength - 50MG/VIAL
The potency of the active ingredient(s), Risperidone. May repeat for multiple part products.

Applicant - JANSSEN PHARMA
The firm name holding legal responsibility for Risperdal Consta. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021346
The FDA assigned number to Risperdal Consta. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Risperdal Consta. 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 - Oct 29, 2003
The date Risperdal Consta 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 Risperdal Consta. 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 Risperdal Consta is in. Format is RX, OTC, DISCN.

Applicant Full Name - Janssen Pharmaceutica Products Lp
The full name of the firm holding legal responsibility for the new application of Risperdal Consta.

Risperdal Consta