Nystex
Drug - Nystex
The trade name of the product as shown on the labeling.
Dosage -
SUSPENSION; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Nystatin
Multiple ingredients are in alphabetical order.
Strength -
100,000 UNITS/ML
The potency of the active ingredient(s), Nystatin. May repeat for multiple part products.
Applicant -
SAVAGE LABS
The firm name holding legal responsibility for Nystex. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
062519
The FDA assigned number to Nystex. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Nystex. 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 -
Jul 6, 1984
The date Nystex 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 Nystex. 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 Nystex 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 Nystex.
Nystex
Nystatin 100,000 Units/ml Suspension; Oral Nystatin 100,000 Units/ml Suspension; Oral Nystatin 100,000 Units/ml Suspension; Oral Nystatin 100,000 Units/ml Suspension; Oral Nystatin 100,000 Units/ml Suspension; Oral Nystatin 100,000 Units/ml Suspension; Oral Nystatin 100,000 Units/ml Suspension; Oral Nystex 100,000 Units/ml Suspension; Oral Nystatin 100,000 Units/ml Suspension; Oral Nystatin 100,000 Units/ml Suspension; Oral
NewDrugInformation
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