Colazal
Drug - Colazal
The trade name of the product as shown on the labeling.
Dosage -
CAPSULE; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Balsalazide Disodium
Multiple ingredients are in alphabetical order.
Strength -
750MG
The potency of the active ingredient(s), Balsalazide Disodium. May repeat for multiple part products.
Applicant -
SALIX PHARMS
The firm name holding legal responsibility for Colazal. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020610
The FDA assigned number to Colazal. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Colazal. 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 18, 2000
The date Colazal 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 Colazal. 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 Colazal is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Salix Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Colazal.
Colazal
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