Hydroxyzine Hcl

   
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Hydroxyzine Hcl


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

Strength - 10MG
The potency of the active ingredient(s), Hydroxyzine Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 088540
The FDA assigned number to Hydroxyzine Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Hydroxyzine 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 - Oct 22, 1985
The date Hydroxyzine 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 Hydroxyzine 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 Hydroxyzine Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Quantum Pharmics Ltd
The full name of the firm holding legal responsibility for the new application of Hydroxyzine Hcl.

Hydroxyzine Hcl