Motrin Ib

   
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Motrin Ib


Drug - Motrin Ib
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 - 200MG
The potency of the active ingredient(s), Ibuprofen. May repeat for multiple part products.

Applicant - MCNEIL
The firm name holding legal responsibility for Motrin Ib. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019012
The FDA assigned number to Motrin Ib. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Motrin Ib. 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 17, 1990
The date Motrin Ib 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 Motrin Ib. 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 Motrin Ib is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mcneil Consumer Products Co Div Mcneilab Inc
The full name of the firm holding legal responsibility for the new application of Motrin Ib.

Motrin Ib