Children's Ibuprofen

   
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Children's Ibuprofen


Drug - Children's Ibuprofen
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
Multiple ingredients are in alphabetical order.

Strength - 100MG/5ML
The potency of the active ingredient(s), Ibuprofen. May repeat for multiple part products.

Applicant - PERRIGO
The firm name holding legal responsibility for Children's Ibuprofen. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 074937
The FDA assigned number to Children's Ibuprofen. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Children's Ibuprofen. 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 22, 1998
The date Children's Ibuprofen 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 Ibuprofen. 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 Ibuprofen is in. Format is RX, OTC, DISCN.

Applicant Full Name - L Perrigo Co
The full name of the firm holding legal responsibility for the new application of Children's Ibuprofen.

Children's Ibuprofen