Midol
Drug - Midol
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 -
BAYER
The firm name holding legal responsibility for Midol. The firm name is condensed to a maximum twenty character unique string.
New Drug Application (NDA) Number -
071001
The FDA assigned number to Midol. Format is nnnnnn.
Product Number -
001
The FDA assigned number to identify Midol. 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 -
Sep 2, 1987
The date Midol 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 Midol. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.
Type -
DISCN
The group or category of approved drugs Midol is in. Format is RX, OTC, DISCN.
Applicant Full Name -
Bayer Healthcare Llc
The full name of the firm holding legal responsibility for the new application of Midol.
Midol
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