Children's Advil Cold
Drug - Children's Advil Cold
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) -
Ibuprofen; Pseudoephedrine Hydrochloride
Multiple ingredients are in alphabetical order.
Strength -
100MG/5ML;15MG/5ML
The potency of the active ingredient(s), Ibuprofen; Pseudoephedrine Hydrochloride. May repeat for multiple part products.
Applicant -
WYETH CONS
The firm name holding legal responsibility for Children's Advil Cold. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
021373
The FDA assigned number to Children's Advil Cold. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Children's Advil Cold. 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 -
Apr 18, 2002
The date Children's Advil Cold 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 Children's Advil Cold. 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 Children's Advil Cold 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 Children's Advil Cold.
Children's Advil Cold
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