Tycolet

   
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Tycolet


Drug - Tycolet
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; Hydrocodone Bitartrate
Multiple ingredients are in alphabetical order.

Strength - 500MG;5MG
The potency of the active ingredient(s), Acetaminophen; Hydrocodone Bitartrate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 089385
The FDA assigned number to Tycolet. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Tycolet. 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 - Aug 27, 1986
The date Tycolet 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 Tycolet. 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 Tycolet 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 Tycolet.

Tycolet