Enlon-plus

   
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Enlon-plus


Drug - Enlon-plus
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) - Atropine Sulfate; Edrophonium Chloride
Multiple ingredients are in alphabetical order.

Strength - 0.14MG/ML;10MG/ML
The potency of the active ingredient(s), Atropine Sulfate; Edrophonium Chloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 019678
The FDA assigned number to Enlon-plus. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Enlon-plus. 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 - Nov 6, 1991
The date Enlon-plus 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 Enlon-plus. 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 Enlon-plus 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 Enlon-plus.

Enlon-plus