Children's Motrin Cold

   
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Children's Motrin Cold


Drug - Children's Motrin 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 - MCNEIL CONS SPECLT
The firm name holding legal responsibility for Children's Motrin Cold. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 021128
The FDA assigned number to Children's Motrin Cold. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Children's Motrin 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 - Aug 1, 2000
The date Children's Motrin 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) - Yes
The pioneer or innovator of Children's Motrin 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 Motrin Cold is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mcneil Consumer And Specialty Pharmaceuticals Div Mcneil Pcc Inc
The full name of the firm holding legal responsibility for the new application of Children's Motrin Cold.

Children's Motrin Cold