Septra Grape

   
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Septra Grape


Drug - Septra Grape
The trade name of the product as shown on the labeling.

Dosage - SUSPENSION; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Sulfamethoxazole; Trimethoprim
Multiple ingredients are in alphabetical order.

Strength - 200MG/5ML;40MG/5ML
The potency of the active ingredient(s), Sulfamethoxazole; Trimethoprim. May repeat for multiple part products.

Applicant - MONARCH PHARMS
The firm name holding legal responsibility for Septra Grape. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017598
The FDA assigned number to Septra Grape. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Septra Grape. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Feb 12, 1986
The date Septra Grape 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 Septra Grape. 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 Septra Grape is in. Format is RX, OTC, DISCN.

Applicant Full Name - Monarch Pharmaceuticals Inc
The full name of the firm holding legal responsibility for the new application of Septra Grape.

Septra Grape