Acilac

   
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Acilac


Drug - Acilac
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 - TECHNILAB
The firm name holding legal responsibility for Acilac. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 073685
The FDA assigned number to Acilac. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Acilac. 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 - May 28, 1993
The date Acilac 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 Acilac. 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 Acilac is in. Format is RX, OTC, DISCN.

Applicant Full Name - Technilab Inc
The full name of the firm holding legal responsibility for the new application of Acilac.

Acilac