Mirapex

   
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Mirapex


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

Dosage - TABLET; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 0.25MG
The potency of the active ingredient(s), Pramipexole Dihydrochloride. May repeat for multiple part products.

Applicant - BOEHRINGER INGELHEIM
The firm name holding legal responsibility for Mirapex. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020667
The FDA assigned number to Mirapex. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Mirapex. 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 - Jul 1, 1997
The date Mirapex 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 Mirapex. 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 Mirapex is in. Format is RX, OTC, DISCN.

Applicant Full Name - Boehringer Ingelheim
The full name of the firm holding legal responsibility for the new application of Mirapex.

Mirapex