Regitine

   
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Regitine


Drug - Regitine
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) - Phentolamine Mesylate
Multiple ingredients are in alphabetical order.

Strength - 5MG/VIAL
The potency of the active ingredient(s), Phentolamine Mesylate. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 008278
The FDA assigned number to Regitine. Format is nnnnnn.

Product Number - 003
The FDA assigned number to identify Regitine. 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 - Approved Prior to Jan 1, 1982
The date Regitine 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 Regitine. 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 Regitine is in. Format is RX, OTC, DISCN.

Applicant Full Name - Novartis Pharmaceuticals Corp
The full name of the firm holding legal responsibility for the new application of Regitine.

Regitine