Edex

   
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Edex


Drug - Edex
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) - Alprostadil
Multiple ingredients are in alphabetical order.

Strength - 0.005MG/VIAL
The potency of the active ingredient(s), Alprostadil. May repeat for multiple part products.

Applicant - SCHWARZ PHARMA
The firm name holding legal responsibility for Edex. The firm name is condensed to a maximum twenty character unique string.

New Drug Application (NDA) Number - 020649
The FDA assigned number to Edex. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Edex. 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 - Jun 12, 1997
The date Edex 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 Edex. 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 Edex is in. Format is RX, OTC, DISCN.

Applicant Full Name - Schwarz Pharma Ag
The full name of the firm holding legal responsibility for the new application of Edex.

Edex