Campral
Drug - Campral
The trade name of the product as shown on the labeling.
Dosage -
TABLET, DELAYED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Acamprosate Calcium
Multiple ingredients are in alphabetical order.
Strength -
333MG
The potency of the active ingredient(s), Acamprosate Calcium. May repeat for multiple part products.
Applicant -
FOREST LABS
The firm name holding legal responsibility for Campral. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
021431
The FDA assigned number to Campral. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Campral. 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 -
Jul 29, 2004
The date Campral 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 Campral. 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 Campral is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Forest Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Campral.
Campral
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