Pediatric Advil

   
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Pediatric Advil


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

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

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

Strength - 100MG/2.5ML
The potency of the active ingredient(s), Ibuprofen. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020812
The FDA assigned number to Pediatric Advil. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Pediatric Advil. 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 - Jan 30, 1998
The date Pediatric Advil 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) - Yes
The pioneer or innovator of Pediatric Advil. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - OTC
The group or category of approved drugs Pediatric Advil is in. Format is RX, OTC, DISCN.

Applicant Full Name - Wyeth Consumer Healthcare
The full name of the firm holding legal responsibility for the new application of Pediatric Advil.

Pediatric Advil