Halflytely

   
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Halflytely


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

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

Active Ingredient(s) - Bisacodyl; Polyethylene Glycol; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride
Multiple ingredients are in alphabetical order.

Strength - 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM
The potency of the active ingredient(s), Bisacodyl; Polyethylene Glycol; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride. May repeat for multiple part products.

Applicant - BRAINTREE
The firm name holding legal responsibility for Halflytely. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021551
The FDA assigned number to Halflytely. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Halflytely. 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 10, 2004
The date Halflytely 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) - Yes
The pioneer or innovator of Halflytely. 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 Halflytely is in. Format is RX, OTC, DISCN.

Applicant Full Name - Braintree Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Halflytely.

Halflytely