Versed

   
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Versed


Drug - Versed
The trade name of the product as shown on the labeling.

Dosage - INJECTABLE; INJECTION
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Midazolam Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 5MG BASE/ML
The potency of the active ingredient(s), Midazolam Hydrochloride. May repeat for multiple part products.

Applicant - HLR
The firm name holding legal responsibility for Versed. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 018654
The FDA assigned number to Versed. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Versed. 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 - Dec 20, 1985
The date Versed 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 Versed. 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 Versed is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hlr Technology
The full name of the firm holding legal responsibility for the new application of Versed.

Versed