Junior Strength Advil
Drug - Junior Strength Advil
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) -
Ibuprofen
Multiple ingredients are in alphabetical order.
Strength -
100MG
The potency of the active ingredient(s), Ibuprofen. May repeat for multiple part products.
Applicant -
WYETH CONS
The firm name holding legal responsibility for Junior Strength Advil. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
020267
The FDA assigned number to Junior Strength Advil. Format is nnnnnn.
Product Number -
002
The FDA assigned number to identify Junior Strength 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 -
Dec 13, 1996
The date Junior Strength 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) -
No
The pioneer or innovator of Junior Strength 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 Junior Strength 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 Junior Strength Advil.
Junior Strength Advil
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