Romazicon

   
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Romazicon


Drug - Romazicon
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) - Flumazenil
Multiple ingredients are in alphabetical order.

Strength - 1MG/10ML (0.1MG/ML)
The potency of the active ingredient(s), Flumazenil. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020073
The FDA assigned number to Romazicon. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Romazicon. 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 - Dec 20, 1991
The date Romazicon 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) - Yes
The pioneer or innovator of Romazicon. 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 Romazicon 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 Romazicon.

Romazicon