Tylenol W/ Codeine No. 1

   
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Tylenol W/ Codeine No. 1


Drug - Tylenol W/ Codeine No. 1
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) - Acetaminophen; Codeine Phosphate
Multiple ingredients are in alphabetical order.

Strength - 300MG;7.5MG
The potency of the active ingredient(s), Acetaminophen; Codeine Phosphate. May repeat for multiple part products.

Applicant - ORTHO MCNEIL PHARM
The firm name holding legal responsibility for Tylenol W/ Codeine No. 1. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 085055
The FDA assigned number to Tylenol W/ Codeine No. 1. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Tylenol W/ Codeine No. 1. 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 - Approved Prior to Jan 1, 1982
The date Tylenol W/ Codeine No. 1 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 Tylenol W/ Codeine No. 1. 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 Tylenol W/ Codeine No. 1 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Ortho Mcneil Pharmaceutical Inc
The full name of the firm holding legal responsibility for the new application of Tylenol W/ Codeine No. 1.

Tylenol W/ Codeine No. 1