Permax

   
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Permax


Drug - Permax
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) - Pergolide Mesylate
Multiple ingredients are in alphabetical order.

Strength - EQ 1MG BASE
The potency of the active ingredient(s), Pergolide Mesylate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019385
The FDA assigned number to Permax. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Permax. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Dec 30, 1988
The date Permax 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 Permax. 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 Permax is in. Format is RX, OTC, DISCN.

Applicant Full Name - Valeant Pharmaceuticals International
The full name of the firm holding legal responsibility for the new application of Permax.

Permax