Talwin 50

   
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Talwin 50


Drug - Talwin 50
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) - Pentazocine Hydrochloride
Multiple ingredients are in alphabetical order.

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

Applicant - SANOFI SYNTHELABO
The firm name holding legal responsibility for Talwin 50. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 016732
The FDA assigned number to Talwin 50. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Talwin 50. 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 Talwin 50 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 Talwin 50. 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 Talwin 50 is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sanofi Synthelabo Inc
The full name of the firm holding legal responsibility for the new application of Talwin 50.

Talwin 50