Lactulose
Drug - Lactulose
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 -
PACO
The firm name holding legal responsibility for Lactulose. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
072029
The FDA assigned number to Lactulose. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Lactulose. 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 -
Aug 25, 1992
The date Lactulose 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 Lactulose. 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 Lactulose is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Paco Pharmaceutical Services Inc
The full name of the firm holding legal responsibility for the new application of Lactulose.
Lactulose
Generlac 10gm/15ml Solution; Oral, Rectal Generlac 10gm/15ml Solution; Oral, Rectal Heptalac 10gm/15ml Solution; Oral, Rectal Lactulose 10gm/15ml Solution; Oral, Rectal Lactulose 10gm/15ml Solution; Oral, Rectal Lactulose 10gm/15ml Solution; Oral, Rectal Acilac 10gm/15ml Solution; Oral, Rectal Cephulac 10gm/15ml Solution; Oral, Rectal Cholac 10gm/15ml Solution; Oral, Rectal Enulose 10gm/15ml Solution; Oral, Rectal
NewDrugInformation
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