Apokyn

   
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Apokyn


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

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

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

Strength - 20MG/2ML (10MG/ML)
The potency of the active ingredient(s), Apomorphine Hydrochloride. May repeat for multiple part products.

Applicant - MYLAN BERTEK
The firm name holding legal responsibility for Apokyn. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021264
The FDA assigned number to Apokyn. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Apokyn. 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 - Apr 20, 2004
The date Apokyn 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 Apokyn. 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 Apokyn is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mylan Bertek Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Apokyn.

Apokyn