Mykacet

   
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Mykacet


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

Dosage - OINTMENT; TOPICAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Nystatin; Triamcinolone Acetonide
Multiple ingredients are in alphabetical order.

Strength - 100,000 UNITS/GM;0.1%
The potency of the active ingredient(s), Nystatin; Triamcinolone Acetonide. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 062733
The FDA assigned number to Mykacet. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Mykacet. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Mar 9, 1987
The date Mykacet 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 Mykacet. 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 Mykacet is in. Format is RX, OTC, DISCN.

Applicant Full Name - Alpharma Us Pharmaceuticals Division
The full name of the firm holding legal responsibility for the new application of Mykacet.

Mykacet