Acetaminophen

   
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Acetaminophen


Drug - Acetaminophen
The trade name of the product as shown on the labeling.

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Acetaminophen
Multiple ingredients are in alphabetical order.

Strength - 650MG
The potency of the active ingredient(s), Acetaminophen. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 075077
The FDA assigned number to Acetaminophen. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Acetaminophen. 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 - Feb 25, 2000
The date Acetaminophen 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 Acetaminophen. 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 Acetaminophen 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 Acetaminophen.

Acetaminophen