Brevibloc In Plastic Container

   
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Brevibloc In Plastic Container


Drug - Brevibloc In Plastic Container
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) - Esmolol Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - 1GM/100ML
The potency of the active ingredient(s), Esmolol Hydrochloride. May repeat for multiple part products.

Applicant - BAXTER HLTHCARE CORP
The firm name holding legal responsibility for Brevibloc In Plastic Container. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 019386
The FDA assigned number to Brevibloc In Plastic Container. Format is nnnnnn.

Product Number - 004
The FDA assigned number to identify Brevibloc In Plastic Container. 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 - Feb 16, 2001
The date Brevibloc In Plastic Container 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 Brevibloc In Plastic Container. 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 Brevibloc In Plastic Container is in. Format is RX, OTC, DISCN.

Applicant Full Name - Baxter Healthcare Corp Anesthesia Critical Care
The full name of the firm holding legal responsibility for the new application of Brevibloc In Plastic Container.

Brevibloc In Plastic Container