Acetaminophen And Tramadol Hcl

   
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Acetaminophen And Tramadol Hcl


Drug - Acetaminophen And 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) - Acetaminophen; Tramadol Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 325MG;37.5MG
The potency of the active ingredient(s), Acetaminophen; Tramadol Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 076475
The FDA assigned number to Acetaminophen And Tramadol Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Acetaminophen And 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 - Apr 21, 2005
The date Acetaminophen And 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 Acetaminophen And 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 Acetaminophen And Tramadol Hcl is in. Format is RX, OTC, DISCN.

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

Acetaminophen And Tramadol Hcl