Reversol

   
Google
 
Web NewDrugInformation.com

Reversol


Drug - Reversol
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) - Edrophonium Chloride
Multiple ingredients are in alphabetical order.

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

Applicant - ORGANON USA INC
The firm name holding legal responsibility for Reversol. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 089624
The FDA assigned number to Reversol. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Reversol. 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 - May 13, 1988
The date Reversol 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 Reversol. 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 Reversol is in. Format is RX, OTC, DISCN.

Applicant Full Name - Organon Usa Inc
The full name of the firm holding legal responsibility for the new application of Reversol.

Reversol