Revex

   
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Revex


Drug - Revex
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) - Nalmefene Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 1MG BASE/ML
The potency of the active ingredient(s), Nalmefene Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 020459
The FDA assigned number to Revex. Format is nnnnnn.

Product Number - 002
The FDA assigned number to identify Revex. 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 - Apr 17, 1995
The date Revex 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 Revex. 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 Revex 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 Revex.

Revex