Bretylol

   
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Bretylol


Drug - Bretylol
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) - Bretylium Tosylate
Multiple ingredients are in alphabetical order.

Strength - 50MG/ML
The potency of the active ingredient(s), Bretylium Tosylate. May repeat for multiple part products.

Applicant - MAYNE PHARMA USA
The firm name holding legal responsibility for Bretylol. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017954
The FDA assigned number to Bretylol. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Bretylol. 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 - Approved Prior to Jan 1, 1982
The date Bretylol 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 Bretylol. 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 Bretylol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Mayne Pharma Usa Inc
The full name of the firm holding legal responsibility for the new application of Bretylol.

Bretylol


Bretylium Tosylate In Dextrose 5% In Plastic Container 400mg/100ml Injectable; Injection
Bretylium Tosylate In Dextrose 5% In Plastic Container 800mg/100ml Injectable; Injection
Bretylium Tosylate In Plastic Container 50mg/ml Injectable; Injection
Bretylol 50mg/ml Injectable; Injection
Bretylium Tosylate In Dextrose 5% In Plastic Container 100mg/100ml Injectable; Injection
Bretylium Tosylate In Dextrose 5% In Plastic Container 200mg/100ml Injectable; Injection
Bretylium Tosylate In Dextrose 5% In Plastic Container 400mg/100ml Injectable; Injection
Bretylium Tosylate In Dextrose 5% In Plastic Container 200mg/100ml Injectable; Injection
Bretylium Tosylate In Dextrose 5% In Plastic Container 400mg/100ml Injectable; Injection
Bretylium Tosylate In Dextrose 5% In Plastic Container 200mg/100ml Injectable; Injection

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