Amoxicillin Pediatric


Amoxicillin Pediatric

Drug - Amoxicillin Pediatric
The trade name of the product as shown on the labeling.

The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Amoxicillin
Multiple ingredients are in alphabetical order.

Strength - 50MG/ML
The potency of the active ingredient(s), Amoxicillin. May repeat for multiple part products.

Applicant - TEVA
The firm name holding legal responsibility for Amoxicillin Pediatric. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 061931
The FDA assigned number to Amoxicillin Pediatric. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Amoxicillin Pediatric. 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 - Dec 1, 1982
The date Amoxicillin 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 Amoxicillin Pediatric. 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 Amoxicillin Pediatric is in. Format is RX, OTC, DISCN.

Applicant Full Name - Teva Pharmaceuticals Usa Inc
The full name of the firm holding legal responsibility for the new application of Amoxicillin Pediatric.

Amoxicillin Pediatric