Bactrim Pediatric

   
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Bactrim Pediatric


Drug - Bactrim Pediatric
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 - MUTUAL PHARM
The firm name holding legal responsibility for Bactrim Pediatric. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017560
The FDA assigned number to Bactrim Pediatric. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Bactrim Pediatric. 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 Bactrim Pediatric 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 Bactrim Pediatric. 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 Bactrim Pediatric is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mutual Pharmaceutical Co Inc
The full name of the firm holding legal responsibility for the new application of Bactrim Pediatric.

Bactrim Pediatric