Mytrex A

   
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Mytrex A


Drug - Mytrex A
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) - Neomycin Sulfate; Triamcinolone Acetonide
Multiple ingredients are in alphabetical order.

Strength - EQ 3.5MG BASE/GM;0.1%
The potency of the active ingredient(s), Neomycin Sulfate; Triamcinolone Acetonide. May repeat for multiple part products.

Applicant - SAVAGE LABS
The firm name holding legal responsibility for Mytrex A. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 062609
The FDA assigned number to Mytrex A. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Mytrex A. 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 - May 23, 1986
The date Mytrex A 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 Mytrex A. 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 Mytrex A is in. Format is RX, OTC, DISCN.

Applicant Full Name - Savage Laboratories Inc Div Altana Inc
The full name of the firm holding legal responsibility for the new application of Mytrex A.

Mytrex A