Gantanol-ds
Drug - Gantanol-ds
The trade name of the product as shown on the labeling.
Dosage -
TABLET; ORAL
The product dosage form and route separated by a semi-colon.
Active Ingredient(s) -
Sulfamethoxazole
Multiple ingredients are in alphabetical order.
Strength -
1GM
The potency of the active ingredient(s), Sulfamethoxazole. May repeat for multiple part products.
Applicant -
ROCHE
The firm name holding legal responsibility for Gantanol-ds. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
012715
The FDA assigned number to Gantanol-ds. Format is nnnnnn.
Product Number -
003
The FDA assigned number to identify Gantanol-ds. 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 Gantanol-ds 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 Gantanol-ds. 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 Gantanol-ds is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Hoffmann La Roche Inc
The full name of the firm holding legal responsibility for the new application of Gantanol-ds.
Gantanol-ds
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