Mycelex

   
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Mycelex


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

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

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

Strength - 10MG
The potency of the active ingredient(s), Clotrimazole. May repeat for multiple part products.

Applicant - BAYER PHARMS
The firm name holding legal responsibility for Mycelex. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018713
The FDA assigned number to Mycelex. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Mycelex. 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 - Jun 17, 1983
The date Mycelex 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 Mycelex. 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 Mycelex is in. Format is RX, OTC, DISCN.

Applicant Full Name - Bayer Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Mycelex.

Mycelex