K-dur 10

   
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K-dur 10


Drug - K-dur 10
The trade name of the product as shown on the labeling.

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

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

Strength - 10MEQ
The potency of the active ingredient(s), Potassium Chloride. May repeat for multiple part products.

Applicant - KEY PHARMS
The firm name holding legal responsibility for K-dur 10. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019439
The FDA assigned number to K-dur 10. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify K-dur 10. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Jun 13, 1986
The date K-dur 10 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 K-dur 10. 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 K-dur 10 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Key Pharmaceuticals Inc Sub Schering Plough Corp
The full name of the firm holding legal responsibility for the new application of K-dur 10.

K-dur 10