Cerumenex

   
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Cerumenex


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

Dosage - SOLUTION/DROPS; OTIC
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Trolamine Polypeptide Oleate Condensate
Multiple ingredients are in alphabetical order.

Strength - 10%
The potency of the active ingredient(s), Trolamine Polypeptide Oleate Condensate. May repeat for multiple part products.

Applicant - PURDUE FREDERICK
The firm name holding legal responsibility for Cerumenex. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 011340
The FDA assigned number to Cerumenex. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Cerumenex. 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 Cerumenex 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 Cerumenex. 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 Cerumenex is in. Format is RX, OTC, DISCN.

Applicant Full Name - Purdue Frederick Co
The full name of the firm holding legal responsibility for the new application of Cerumenex.

Cerumenex