Glycolax

   
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Glycolax


Drug - Glycolax
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) - Polyethylene Glycol 3350
Multiple ingredients are in alphabetical order.

Strength - 17GM/SCOOPFUL
The potency of the active ingredient(s), Polyethylene Glycol 3350. May repeat for multiple part products.

Applicant - SCHWARZ PHARMA
The firm name holding legal responsibility for Glycolax. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 076652
The FDA assigned number to Glycolax. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Glycolax. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

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

Approval Date - Jul 2, 2004
The date Glycolax 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 Glycolax. 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 Glycolax is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schwarz Pharma Ag
The full name of the firm holding legal responsibility for the new application of Glycolax.

Glycolax