Midazolam Hcl

   
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Midazolam Hcl


Drug - Midazolam Hcl
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 - HOSPIRA
The firm name holding legal responsibility for Midazolam Hcl. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 075409
The FDA assigned number to Midazolam Hcl. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Midazolam Hcl. Each strength is a separate product. May repeat for multiple part products. Format is nnn.

Therapeutic Equivalence (TE) Code - AP
The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products.

Approval Date - Jun 20, 2000
The date Midazolam 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 Midazolam 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 Midazolam Hcl is in. Format is RX, OTC, DISCN.

Applicant Full Name - Hospira Inc
The full name of the firm holding legal responsibility for the new application of Midazolam Hcl.

Midazolam Hcl