Generlac

   
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Generlac


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

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

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

Strength - 10GM/15ML
The potency of the active ingredient(s), Lactulose. May repeat for multiple part products.

Applicant - MORTON GROVE
The firm name holding legal responsibility for Generlac. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 071842
The FDA assigned number to Generlac. Format is nnnnnn.

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

Applicant Full Name - Morton Grove Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Generlac.

Generlac