Barstatin 100

   
Google
 
Web NewDrugInformation.com

Barstatin 100


Drug - Barstatin 100
The trade name of the product as shown on the labeling.

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

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

Strength - 100%
The potency of the active ingredient(s), Nystatin. May repeat for multiple part products.

Applicant - BARLAN
The firm name holding legal responsibility for Barstatin 100. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 062489
The FDA assigned number to Barstatin 100. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Barstatin 100. 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 - Apr 27, 1988
The date Barstatin 100 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 Barstatin 100. 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 Barstatin 100 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Barlan Pharmacal Co Inc
The full name of the firm holding legal responsibility for the new application of Barstatin 100.

Barstatin 100