Sodium Aminosalicylate
Drug - Sodium Aminosalicylate
The trade name of the product as shown on the labeling.
Dosage -
POWDER; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Aminosalicylate Sodium
Multiple ingredients are in alphabetical order.
Strength -
100%
The potency of the active ingredient(s), Aminosalicylate Sodium. May repeat for multiple part products.
Applicant -
HEXCEL
The firm name holding legal responsibility for Sodium Aminosalicylate. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
080097
The FDA assigned number to Sodium Aminosalicylate. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Sodium Aminosalicylate. 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 -
Approved Prior to Jan 1, 1982
The date Sodium Aminosalicylate 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 Sodium Aminosalicylate. 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 Sodium Aminosalicylate is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Hexcel Chemical Products
The full name of the firm holding legal responsibility for the new application of Sodium Aminosalicylate.
Sodium Aminosalicylate
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