Proquin Xr

   
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Proquin Xr


Drug - Proquin Xr
The trade name of the product as shown on the labeling.

Dosage - TABLET, EXTENDED RELEASE; ORAL
The product dosage form and route separated by a semi-colon.

Active Ingredient(s) - Ciprofloxacin Hydrochloride
Multiple ingredients are in alphabetical order.

Strength - EQ 500MG BASE
The potency of the active ingredient(s), Ciprofloxacin Hydrochloride. May repeat for multiple part products.

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

New Drug Application (NDA) Number - 021744
The FDA assigned number to Proquin Xr. Format is nnnnnn.

Product Number - 001
The FDA assigned number to identify Proquin Xr. 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 19, 2005
The date Proquin Xr 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 Proquin Xr. 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 Proquin Xr is in. Format is RX, OTC, DISCN.

Applicant Full Name - Esprit Pharma Inc
The full name of the firm holding legal responsibility for the new application of Proquin Xr.

Proquin Xr