Azo Gantanol
Drug - Azo Gantanol
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) -
Phenazopyridine Hydrochloride; Sulfamethoxazole
Multiple ingredients are in alphabetical order.
Strength -
100MG;500MG
The potency of the active ingredient(s), Phenazopyridine Hydrochloride; Sulfamethoxazole. May repeat for multiple part products.
Applicant -
ROCHE
The firm name holding legal responsibility for Azo Gantanol. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
013294
The FDA assigned number to Azo Gantanol. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Azo Gantanol. 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 -
Sep 10, 1987
The date Azo Gantanol 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 Azo Gantanol. 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 Azo Gantanol 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 Azo Gantanol.
Azo Gantanol
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