Tramadol Hcl

   
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Tramadol Hcl


Drug - Tramadol Hcl
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) - Tramadol Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 50MG
The potency of the active ingredient(s), Tramadol Hydrochloride. May repeat for multiple part products.

Applicant - PLIVA
The firm name holding legal responsibility for Tramadol Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075982
The FDA assigned number to Tramadol Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Tramadol Hcl. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AB
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jul 1, 2002
The date Tramadol Hcl 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 Tramadol Hcl. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No.

Type - RX
The group or category of approved drugs Tramadol Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Pliva Inc
The full name of the firm holding legal responsibility for the new application of Tramadol Hcl.

Tramadol Hcl