Pertofrane

   
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Pertofrane


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

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

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

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

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

New Drug Application (NDA) Number - 013621
The FDA assigned number to Pertofrane. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Pertofrane. 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 - Approved Prior to Jan 1, 1982
The date Pertofrane 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 Pertofrane. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - DISCN
The group or category of approved drugs Pertofrane is in. Format is RX, OTC, DISCN.

Applicant Full Name - Aventis Pharmaceutical Products Inc
The full name of the firm holding legal responsibility for the new application of Pertofrane.

Pertofrane