Thioridazine Hcl

   
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Thioridazine Hcl


Drug - Thioridazine 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) - Thioridazine Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 25MG
The potency of the active ingredient(s), Thioridazine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 088664
The FDA assigned number to Thioridazine Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Thioridazine Hcl. 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 - Mar 15, 1984
The date Thioridazine 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 Thioridazine Hcl. 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 Thioridazine Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Roxane Laboratories Inc
The full name of the firm holding legal responsibility for the new application of Thioridazine Hcl.

Thioridazine Hcl