Regonol

   
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Regonol


Drug - Regonol
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) - Pyridostigmine Bromide
Multiple ingredients are in alphabetical order.

Strength - 5MG/ML
The potency of the active ingredient(s), Pyridostigmine Bromide. May repeat for multiple part products.

Applicant - SABEX 2002
The firm name holding legal responsibility for Regonol. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 017398
The FDA assigned number to Regonol. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Regonol. 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 Regonol 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 Regonol. 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 Regonol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Sabex 2002 Inc
The full name of the firm holding legal responsibility for the new application of Regonol.

Regonol