Mytrex F
Drug - Mytrex F
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 -
SAVAGE LABS
The firm name holding legal responsibility for Mytrex F. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
062601
The FDA assigned number to Mytrex F. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Mytrex F. 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 -
Oct 9, 1985
The date Mytrex F 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 F. 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 F 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 F.
Mytrex F
Myco-triacet Ii 100,000 Units/gm;0.1% Ointment; Topical Mykacet 100,000 Units/gm;0.1% Ointment; Topical Mytrex F 100,000 Units/gm;0.1% Ointment; Topical Nystatin And Triamcinolone Acetonide 100,000 Units/gm;0.1% Cream; Topical Nystatin And Triamcinolone Acetonide 100,000 Units/gm;0.1% Cream; Topical Nystatin And Triamcinolone Acetonide 100,000 Units/gm;0.1% Cream; Topical Nystatin And Triamcinolone Acetonide 100,000 Units/gm;0.1% Cream; Topical Nystatin-triamcinolone Acetonide 100,000 Units/gm;0.1% Cream; Topical Nystatin-triamcinolone Acetonide 100,000 Units/gm;0.1% Cream; Topical Mycolog-ii 100,000 Units/gm;0.1% Ointment; Topical
NewDrugInformation
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